Company · US
Bard Peripheral Vascular Inc
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2026. Name variants (Inc, Corp, punctuation) are merged.
39510(k) clearances (3 in 12 months)
237recalls (3 in 12 months)
211recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 71 |
| KNW | Instrument, Biopsy | 36 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 31 |
| MSD | Catheter, Hemodialysis, Implanted | 31 |
| DQY | Catheter, Percutaneous | 28 |
| PWY | Lumbar Puncture Tray (Adult & Pediatric) | 11 |
| FCG | Biopsy Needle | 8 |
| DTK | Filter, Intravascular, Cardiovascular | 7 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 7 |
| NEU | Marker, Radiographic, Implantable | 5 |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 4 |
| DYB | Introducer, Catheter | 4 |
| QAN | Stent, Iliac Vein | 3 |
| GAE | Snare, Surgical | 2 |
| GDF | Guide, Needle, Surgical | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 |
| JCT | Prosthesis, Tracheal, Expandable | 2 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 2 |
| MCW | Catheter, Peripheral, Atherectomy | 2 |
| PNO | Catheter, Percutaneous, Cutting/Scoring | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 14, 2026 | K262571 | EnCor EnCompass Breast Biopsy and Tissue Removal System Bard Peripheral Vascular, Inc. | KNW |
| Feb 4, 2026 | K260012 | UltraScore Focused Force PTA Balloon Bard Peripheral Vascular, Inc. | PNO |
| Dec 12, 2025 | K252681 | EnCor EnCompass Breast Biopsy and Tissue Removal System Bard Peripheral Vascular, Inc. | KNW |
| Jul 10, 2025 | K250032 | Marquee Disposable Core Biopsy Instrument and Instrument Kit Bard Peripheral Vascular, Inc. | KNW |
| Jun 17, 2025 | K250219 | Dorado PTA Balloon Dilatation Catheter Bard Peripheral Vascular, Inc. | DQY |
| Mar 24, 2025 | K243642 | UltraCor Twirl Breast Tissue Marker Bard Peripheral Vascular, Inc. | NEU |
| Jan 30, 2025 | K242757 | Rotarex Atherectomy System Bard Peripheral Vascular, Inc. | MCW |
| Dec 6, 2024 | K241946 | PeritX 1L Drainage Kit (90-1010); PeritX 2L Drainage Kit (90-2010); PeritX Peritoneal Catheter Kit (50-9000C); PeritX Bard Peripheral Vascular, Inc. | PNG |
| Dec 8, 2023 | K232737 | PowerPort ClearVUE Slim ECG Enabled Implantable Port; PowerPort ClearVUE isp ECG Enabled Implantable Port; PowerPort Bard Peripheral Vascular, Inc. | LJT |
| May 31, 2022 | K221440 | Liverty TIPS Access Set Bard Peripheral Vascular, Inc. | DYB |
| Mar 30, 2022 | K213896 | BD Trek Powered Bone Biopsy System Bard Peripheral Vascular | KNW |
| Jul 15, 2021 | K211933 | EleVation Breast Biopsy System Bard Peripheral Vascular | KNW |
| Jun 4, 2021 | K211410 | GlidePath 13F Long-Term Hemodialysis Catheter Bard Peripheral Vascular, Inc. | MSD |
| Nov 7, 2019 | K192948 | EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G Bard Peripheral Vascular, Inc. | KNW |
| Oct 3, 2019 | K192318 | Ultraverse 014 and 018 PTA Balloon Dilatation Catheters Bard Peripheral Vascular, Inc. | LIT |
| Mar 9, 2018 | K180061 | UltraCor Twirl Breast Tissue Marker Bard Peripheral Vascular, Inc. | NEU |
| Sep 14, 2017 | K171953 | Bard Mission Disposable Core Biopsy Instrument Bard Peripheral Vascular, Inc. | KNW |
| Jun 14, 2017 | K163420 | UltraScore Focused Force PTA Balloon Bard Peripheral Vascular, Inc. | PNO |
| Aug 4, 2016 | K161986 | SIDEKICK and USHER Support Catheters Bard Peripheral Vascular, Inc. | DQY |
| May 13, 2016 | K152510 | UltraCor Twirl Breast Tissue Marker Bard Peripheral Vascular, Inc. | NEU |
| Sep 24, 2014 | K142261 | Ultraverse 035 PTA Balloon Dilatation Catheter Bard Peripheral Vascular, Inc. | LIT |
| Feb 21, 2014 | K133948 | BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT Bard Peripheral Vascular, Inc. | KNW |
| Dec 20, 2013 | K133569 | TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM Bard Peripheral Vascular, Inc. | OZT |
| May 30, 2013 | K131199 | ULTRAVERSE RX PTA BALLOON DILATATION CATHETER Bard Peripheral Vascular, Inc. | LIT |
| Apr 19, 2012 | K120971 | ATLAS PTA BALLOON DILATATION CATHETER Bard Peripheral Vascular, Inc. | LIT |
| Apr 19, 2012 | K120722 | RIVAL PTA DILATATION CATHETER Bard Peripheral Vascular, Inc. | LIT |
| Mar 15, 2012 | K120660 | CONQUEST 40 PTA DILATATION CATHETER Bard Peripheral Vascular, Inc. | LIT |
| Dec 8, 2010 | K103367 | SEEKER CROSSING SUPPORT CATHETER Bard Peripheral Vascular, Inc. | DQY |
| May 30, 2008 | K063532 | BARD E LUMINEXX BILIARY STENT Bard Peripheral Vascular, Inc. | FGE |
| Sep 19, 2007 | K072283 | DORADO PTA BALLOON DILATATION CATHETER Bard Peripheral Vascular, Inc. | DQY |
| Oct 26, 2006 | K062887 | MODIFICATION TO G2 FILTER SYSTEM-FEMORAL DELIVERY KIT, MODEL RF-310F Bard Peripheral Vascular | DTK |
| Nov 25, 2005 | K052578 | BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J Bard Peripheral Vascular, Inc. | DTK |
| Sep 20, 2005 | K052282 | VENAFLO II VASCULAR GRAFT Bard Peripheral Vascular, Inc. | DSY |
| Aug 25, 2005 | K052114 | BARD CONFORMEXX BILIARY STENT WITH THE PERFORMAXX GRIP Bard Peripheral Vascular, Inc. | FGE |
| Aug 23, 2005 | K052236 | BARD ATLAS PTA BALLOON DILATATION CATHETER Bard Peripheral Vascular, Inc. | DQY |
| Jul 7, 2005 | K050832 | FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT Bard Peripheral Vascular, Inc. | JCT |
| Jan 31, 2005 | K050049 | DYNAFLO BYPASS GRAFT Bard Peripheral Vascular, Inc. | DSY |
| Sep 30, 2004 | K042062 | PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE Bard Peripheral Vascular, Inc. | KCT |
| Jun 19, 2003 | K031041 | FLUENCY TRACHEOBRONCHIAL STENT GRAFT Bard Peripheral Vascular | JCT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2026 | Bard Peripheral Vascular Inc EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with software Open, Classified |
KNW | K252681 |
| Feb 13, 2026 | Bard Peripheral Vascular Inc Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060 Open, Classified |
LJS | K830233 K830256 |
| Dec 5, 2025 | Bard Peripheral Vascular Inc Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T, Open, Classified |
PXI | None listed |
| Sep 26, 2025 | Bard Peripheral Vascular Inc Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sop Open, Classified |
GEI | K160754 K211806 +1 |
| Mar 5, 2025 | Bard Peripheral Vascular Inc Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex:
S 6 F x 110 cm, REF: 80236;
S 6 F x 135 cm, REF: 80237;
S 8 F x 85 cm, REF: 80238;
S 8 F x 110 cm, REF: 80239 Open, Classified |
MCW | K172315 K211738 +1 |
| Nov 15, 2024 | Bard Peripheral Vascular Inc Bard Marquee Disposable Core Biopsy Instrument Kit:
BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210;
BARD MARQUEE 12G X 10 CM, REF: MQ1210;
BARD MARQUEE Kit 12G X 13 CM, REF: MQK1213;
BARD MARQUEE 12G X 13 Open, Classified |
KNW | K133948 |
| Nov 13, 2024 | Bard Peripheral Vascular Inc The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to permanently eliminate the Open, Classified |
GEI | K160754 |
| Sep 20, 2024 | Bard Peripheral Vascular Inc BARD MAGNUM Disposable Core Tissue Biopsy Needle REF:
MN1410
MN 1420
MN1610
MN1616
MN1820
MN2010
The Magnum Biopsy System (instrument and needles) is intended for use in obtaining biopsies from soft Open, Classified |
FCG | K934370 |
| Sep 6, 2024 | Bard Peripheral Vascular Inc Guidewire 70cm x 1mm (0.038 ) REF 5583705
These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lumen
Hemodialysis Catheters. Please refer to the applicable catheter Instructions f Open, Classified |
DQX | K770977 |
| Jan 5, 2024 | Bard Peripheral Vascular Inc BD Recanalization System, REF: BDRECANSYSTEM Open, Classified |
PDU | K203363 |
| Jan 5, 2024 | Bard Peripheral Vascular Inc Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM; 1416MSK/ Mission Kit 14G x 16CM; 1610MSK/ Mission Kit 16G x 10CM; 1616MSK/ Mission Kit 16G x 16CM; 1810M Open, Classified |
KNW | K171953 |
| Oct 4, 2023 | Bard Peripheral Vascular Inc Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016 Open, Classified |
KNW | K133948 |
| May 5, 2023 | Bard Peripheral Vascular Inc Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM Open, Classified |
KNW | K171953 |
| Mar 16, 2023 | Bard Peripheral Vascular Inc Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK Open, Classified |
KNW | K171953 |
| Feb 9, 2023 | Bard Peripheral Vascular Inc The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent framework. The inner lumen of the covered stent is carbon impregnated. Open, Classified |
PFV | None listed |
| Feb 1, 2023 | Bard Peripheral Vascular Inc Catalog Number / Product Description
0601600 2.7F Broviac CV Catheter Repair Kit
0601610 4.2 Fr Broviac CV Catheter Repair Kit
0601620 6.6F Broviac CV Catheter Repair Kit
0601630 9.6F Hickman CV Ca Open, Classified |
LJS | K830406 K871998 |
| Apr 22, 2022 | Bard Peripheral Vascular Inc REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO, Open, Classified |
PXI | None listed |
| Jan 20, 2022 | Bard Peripheral Vascular Inc SAFE-T PLUS ATRAUMATIC ADULT LP TRAY Open, Classified |
PWY | None listed |
| Jan 20, 2022 | Bard Peripheral Vascular Inc LUMBAR PUNCTURE DRUG FREE TRAY 22G Open, Classified |
PWY | None listed |
| Jan 20, 2022 | Bard Peripheral Vascular Inc ATRAUMATIC ADULT LUMBAR PUNCTURE TRAY Open, Classified |
PWY | None listed |
| Jan 20, 2022 | Bard Peripheral Vascular Inc SAFE-T PLUS LUMBARPUNCTURE TRAY ADULT Open, Classified |
PWY | None listed |
| Jan 20, 2022 | Bard Peripheral Vascular Inc LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL Open, Classified |
PWY | None listed |
| Jan 20, 2022 | Bard Peripheral Vascular Inc LUMBAR PUNCTURE TRAY ADULT 18G X 3.5 Open, Classified |
PWY | None listed |
| Jan 20, 2022 | Bard Peripheral Vascular Inc SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT Open, Classified |
PWY | None listed |
| Jan 20, 2022 | Bard Peripheral Vascular Inc ADULT LUMBAR PUNCTURE DRUG FREE TRAY 20G Open, Classified |
PWY | None listed |
| Jan 20, 2022 | Bard Peripheral Vascular Inc LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP Open, Classified |
PWY | None listed |
| Jan 20, 2022 | Bard Peripheral Vascular Inc LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5 Open, Classified |
PWY | None listed |
| Jan 20, 2022 | Bard Peripheral Vascular Inc Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with Manometer Open, Classified |
PWY | None listed |
| Aug 24, 2021 | Bard Peripheral Vascular Inc Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/Aspiration needle, sterile, Qty: 10, Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion
Intended use to Terminated |
KNW | K171531 K913306 |
| Aug 24, 2021 | Bard Peripheral Vascular Inc Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4"Biopsy/Aspiration needle, 15 G Aspiration Needle (Adjustable Length 15/16" -1-7/8") (24mm-48mm) sterile, F Terminated |
KNW | K171531 |
| Jul 27, 2021 | Bard Peripheral Vascular Inc REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796 Open, Classified |
FMI | K930217 |
| Jun 23, 2021 | Bard Peripheral Vascular Inc TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm
TIN3015 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 15G x 79mm Open, Classified |
KNW | K930217 |
| Jun 23, 2021 | Bard Peripheral Vascular Inc EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm Open, Classified |
KNW | K171531 |
| Jun 23, 2021 | Bard Peripheral Vascular Inc TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 15 cm;
TJC3513 Jamshidi" Bone Marrow Biopsy/Aspiration Needle. 13G x 8.9 cm;
TJM4011 Jamshidi" Crown B Open, Classified |
KNW | K171531 |
| Mar 25, 2021 | Bard Peripheral Vascular Inc PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 5829502, UDI: (01)00801741027406 - Product Usage: The port system can be used for inf Terminated |
LJT | K090512 |
| Mar 25, 2021 | Bard Peripheral Vascular Inc PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829570, UDI: (01) 00801741027192 - Product Usage: The port system can be used for in Terminated |
LJT | K090512 |
| Mar 25, 2021 | Bard Peripheral Vascular Inc PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829500, UDI: (01) 00801741027185 - Product Usage: The port system can be used for in Terminated |
LJT | K090512 |
| Jan 14, 2021 | Bard Peripheral Vascular Inc BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm REF XXXXXXX
Note - for definition of the "X's refer to Tyvek Lid Label.pdf" uploaded in Associated Documents Terminated |
KNW | K133948 |
| Dec 14, 2020 | Bard Peripheral Vascular Inc VENOVO Venous Stent System 9F
Product Description(REF)/dimension:
VENEL14040 /Venovo 9F 14/40/1200mm OUS;
VENEL14060 /Venovo 9F 14/60/1200mm OUS;
VENEL14080 /Venovo 9F 14/80/1200mm OUS;
VENEL14100 /V Open, Classified |
QAN | None listed |
| Dec 14, 2020 | Bard Peripheral Vascular Inc VENOVO Venous Stent System 8F
Product Description(REF)/dimension:
VENEL10040 /Venovo 8F 10/40/1200mm OUS;
VENEL10060 /Venovo 8F 10/60/1200mm OUS;
VENEL10080 /Venovo 8F 10/80/1200mm OUS;
VENEL10100 /V Open, Classified |
QAN | None listed |
| Dec 14, 2020 | Bard Peripheral Vascular Inc VENOVO Venous Stent System 10F
Product Description(REF)/dimension:
VENEL16040 Venovo 10F 16/40/1200mm OUS
VENEL16060 Venovo 10F 16/60/1200mm OUS
VENEL16080 Venovo 10F 16/80/1200mm OUS
VENEL16100 Veno Open, Classified |
QAN | None listed |
| Oct 1, 2020 | Bard Peripheral Vascular Inc Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat. No. CQ7564, UDI: (01) 00801741062902 - Product Usage: use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal Terminated |
DQY | K083657 |
| Mar 17, 2020 | Bard Peripheral Vascular Inc Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile - Product Code: DJ4011X - Product Usage: The device is comprised of an outer cannula with a handle and an inner Terminated |
KNW | K171531 |
| Jan 15, 2020 | Bard Peripheral Vascular Inc BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and Attachable 6 F Polyurethane Open-Ended Single-Lumen Venous Catheter, Product #5676300 - Product Usage: All materials Open, Classified |
LJT | K122899 |
| Jan 3, 2020 | Bard Peripheral Vascular Inc Bard Biopsy EnCor Probe, MRI, 10G Blunt Tip, REF number ECPMR0110GBT, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile. Terminated |
KNW | K040842 K051158 |
| Jan 3, 2020 | Bard Peripheral Vascular Inc Bard Biopsy EnCor Probe, MRI, 10G Trocar Tip, REF number ECPMR0110G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile. Terminated |
KNW | K040842 K051158 |
| Jan 3, 2020 | Bard Peripheral Vascular Inc Bard Biopsy EnCor Probe, MRI, 7G Trocar Tip, REF number ECPMR017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile. Terminated |
KNW | K040842 K051158 |
| Jan 3, 2020 | Bard Peripheral Vascular Inc Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile. Terminated |
KNW | K040842 K051158 |
| Dec 19, 2019 | Bard Peripheral Vascular Inc LIFESTREAM Balloon Expandable Vascular Covered Stent . BARD PERIPHERAL VASCULAR. 6mm X 26mm X 80 Recommended Introducer 6F (2.00mm) NP 8atm (811 kPa) Recommended Guide wire .035" (0.89mm) RBP 12 at Terminated |
PRL | None listed |
| Oct 25, 2019 | Bard Peripheral Vascular Inc BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymp Terminated |
KNW | K133948 |
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