Panels › General Hospital › Product code LJS · Class 2
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Regulation 880.5970
4510(k)s in 12 months (303 all time)
9recalls in 12 months (332 all time)
305recalls that name a 510(k)
Top companies in LJS
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 24, 2026 | Argon Medical Devices, Inc L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620 Open, Classified |
LJS | K230669 |
| Jul 24, 2026 | Argon Medical Devices, Inc L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF: 384539; 18ga (3.5F) 1.15mm x 60cm, REF: 384464; Basic Kit 28GA (1.2F) x 25cm 1 Lumen), REF: 384516; 20ga (3F) 1. Open, Classified |
LJS | K230669 |
| Jul 2, 2026 | Bard Access Systems, Inc. 1174108 PowerPICC Catheter 4 Fr Single-Lumen
UDI-DI Code: 00801741154935
1295108 PowerPICC SOLO Catheter 5 Fr Dual-Lumen
UDI-DI Code: 00801741034602
1174108D3 PowerPICC Catheter 4 Fr Single-Lumen
UD Open, Classified |
LJS | K210264 |
| Jul 2, 2026 | Bard Access Systems, Inc. 7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen
UDI-DI Code: 00801741035258
The Groshong NXT PICC provides short (less than 30 days) or long (greater than 30 days) term peripheral access to Open, Classified |
LJS | K201452 |
| Jul 2, 2026 | Bard Access Systems, Inc. CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen
UDI-DI Code: 00801741236129
CK000883 PowerPICC Provena Catheter 4 Fr Dual-Lumen
UDI-DI Code: 00801741188800
CK000884A PowerPICC Provena SOLO Open, Classified |
LJS | K180548 |
| Jul 2, 2026 | Bard Access Systems, Inc. 1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110
3173108D PowerPICC SV Catheter 3 Fr Single-Lumen REKV2227 00801741027536
The PowerPlCC SV catheters are intended for short or Open, Classified |
LJS | K102159 |
| Jul 2, 2026 | Bard Access Systems, Inc. CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen
UDI-DI Code: 00801741129674
Catheter stylets provide internal reinforcement to aid in catheter placement. Open, Classified |
LJS | K091324 |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC;
AGBA PICC: 2L 5.5 FR X 45 CM/ASK-44552-ABKB;
AGBA PICC/DELTA KIT: 5.5 FR X 55 CM/ASK-45552-MHBV;
AGBA PICC: 1L 4.5FR x 55CM w Biopatch/DL Open, Classified |
LJS | K042126 K112896 +4 |
| 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 |
| Apr 16, 2025 | Bard Access Systems, Inc. BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118, CK000955, 3174135, CK000617, CK000839, 3194355, 6174118, 3194135, 3194335, 217 Open, Classified |
LJS | K210264 |
| Aug 16, 2024 | Argon Medical Devices, Inc L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539 Open, Classified |
LJS | K230669 |
| Oct 13, 2023 | Access Vascular, Inc HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004 Open, Classified |
LJS | K213550 |
| Oct 13, 2023 | Access Vascular, Inc HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002 Open, Classified |
LJS | K213550 |
| Oct 5, 2023 | ARROW INTERNATIONAL Inc. Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; catheter, intravascular, therapeutic, long-term greater than Open, Classified |
LJS | K160925 |
| Oct 5, 2023 | ARROW INTERNATIONAL Inc. Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Term Intravascular Cath Open, Classified |
LJS | K153487 |
| Sep 15, 2023 | ARROW INTERNATIONAL Inc. Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: Percutaneous, implanted, long-term intravascular catheter Open, Classified |
LJS | K121941 |
| Sep 15, 2023 | ARROW INTERNATIONAL Inc. Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular Open, Classified |
LJS | K073451 |
| May 18, 2023 | Access Vascular, Inc HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004 Open, Classified |
LJS | K193015 |
| 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 |
| Nov 8, 2022 | Access Vascular, Inc. Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter Terminated |
LJS | K193015 |
| May 19, 2021 | Bard Access Systems Inc. 5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire
Unit Label:
PowerPICC REF CK000340B BARD MYPICC KIT 5F French Size Dual-Lumen 70cm Guidewire Terminated |
LJS | None listed |
| May 19, 2021 | Bard Access Systems Inc. 5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire
Instructions For Use:
PowerPicc Polyurethand Radiology PiCC with Microintroducer Terminated |
LJS | K051672 |
| Apr 7, 2021 | Bard Access Systems Inc. REF 7617407, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035248 - Product Usage: is designed for use when central venous catheterization is prescribed. Terminated |
LJS | K063240 K201452 |
| Apr 7, 2021 | Bard Access Systems Inc. REF 7617405, Groshong NXT ClearVue Catheter Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741086998 - Product Usage: is designed for use when central venous catheterization is prescribed. Terminated |
LJS | K063240 K201452 |
| Apr 7, 2021 | Bard Access Systems Inc. REF CK000516, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet, Full Kit, 4F, Single-Lumen, TPS, CE 2797, UDI: (01)10801741107891 - Product Usage: is designed for u Terminated |
LJS | K063240 K201452 |
| Apr 7, 2021 | Bard Access Systems Inc. REF CK000379, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, CE 2797, UDI: (01)10801741102704 - Product Usage: is designed for use when Terminated |
LJS | K063240 K201452 |
| Apr 7, 2021 | Bard Access Systems Inc. REF 91660417, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Tip, Basic Kit, 4F, Single-Lumen, TPS, CE 2797, UDI: (01)10801741107822 - Product Usage: is designed Terminated |
LJS | K063240 K201452 |
| Apr 7, 2021 | Bard Access Systems Inc. REF 69655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741147521 - Product Usage: is designed for use when central Terminated |
LJS | K063240 K201452 |
| Apr 7, 2021 | Bard Access Systems Inc. REF 9655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741036023 - Product Usage: is designed for use when central Terminated |
LJS | K063240 K201452 |
| Apr 7, 2021 | Bard Access Systems Inc. REF 9617408D, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Maximal Barrier Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741036016 - Product Usage: is designed for use wh Terminated |
LJS | K063240 K201452 |
| Apr 7, 2021 | Bard Access Systems Inc. REF 9617408, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741036009 - Product Usage: is designed for use when central v Terminated |
LJS | K063240 K201452 |
| Apr 7, 2021 | Bard Access Systems Inc. REF 9617407, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741035996 - Product Usage: is designed for use when central v Terminated |
LJS | K063240 K201452 |
| Apr 7, 2021 | Bard Access Systems Inc. REF 9617405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741035989 - Product Usage: is designed for use when central Terminated |
LJS | K063240 K201452 |
| Apr 7, 2021 | Bard Access Systems Inc. REF 7812400, Replacement Connector For 4F Groshong NXT clearVue PICC with Extension Leg, Rx Only, Sterile EO, CE 2797, UDI: (01)10801741075268 - Product Usage: is designed for use when central venous Terminated |
LJS | K063240 K201452 |
| Apr 7, 2021 | Bard Access Systems Inc. REF 7655405J, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200615 - Product Usage: is designed for use when central venous catheterization is prescribed. Terminated |
LJS | K063240 K201452 |
| Apr 7, 2021 | Bard Access Systems Inc. REF 7655405, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035279 - Product Usage: is designed for use when central venous catheterization is prescribed. Terminated |
LJS | K063240 K201452 |
| Apr 7, 2021 | Bard Access Systems Inc. REF 7617408D, Groshong NXT ClearVue Catheter, Maximal Barrier Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035262 - Product Usage: is designed for use when central venous catheterization is prescrib Terminated |
LJS | K063240 K201452 |
| Apr 7, 2021 | Bard Access Systems Inc. REF 7617408, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035255 - Product Usage: is designed for use when central venous catheterization is prescribed. Terminated |
LJS | K063240 K201452 |
| Apr 7, 2021 | Bard Access Systems Inc. REF 7617405J, Groshong NXT ClearVue Catheter, Basic kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200592 - Product Usage: is designed for use when central venous catheterization is prescribed. Terminated |
LJS | K063240 K201452 |
| Apr 7, 2021 | Bard Access Systems Inc. REF 7617400, Groshong NXT ClearVue Catheter, intermediate kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741045094 - Product Usage: is designed for use when central venous catheterization is prescribed. Terminated |
LJS | K063240 K201452 |
| May 4, 2020 | Angiodynamics, Inc. BioFlo PICC and Xcela PICC Maximal Barrier Nursing Kits - Product Usage: are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not Terminated |
LJS | None listed |
| May 4, 2020 | Angiodynamics, Inc. BioFlo PICC and Xcela PICC Convenience Kits - Product Usage: are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, Terminated |
LJS | None listed |
| Feb 26, 2020 | Becton Dickinson & Company BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000435 Terminated |
LJS | K091324 |
| Feb 26, 2020 | Becton Dickinson & Company BARD MYPICC KIT 4F Dual-Lumen, Catalog Number CK000418B Terminated |
LJS | K102159 |
| Feb 26, 2020 | Becton Dickinson & Company BARD MYPICC KIT 3F Single-Lumen, Catalog Number CK000417B Terminated |
LJS | K102159 |
| Feb 26, 2020 | Becton Dickinson & Company BARD MYPICC KIT 5F Triple-Lumen, Catalog Number CK000278 Terminated |
LJS | K091324 |
| Feb 26, 2020 | Becton Dickinson & Company BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000277 Terminated |
LJS | K091324 |
| Feb 26, 2020 | Becton Dickinson & Company BARD MYPICC KIT 4F Single-Lumen, Catalog Number CK000276 Terminated |
LJS | K091324 |
| Feb 26, 2020 | Becton Dickinson & Company BARD MYPICC KIT 5F Triple-Lumen, Catalog Number CK000026A Terminated |
LJS | K091324 |
| Feb 26, 2020 | Becton Dickinson & Company BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000025 Terminated |
LJS | K091324 |
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