ClearanceBrief
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)
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Top companies in LJS

DateFirm and productCodeLinked 510(k)
Jul 24, 2026Argon Medical Devices, Inc
L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620
Open, Classified
LJSK230669
Jul 24, 2026Argon 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
LJSK230669
Jul 2, 2026Bard 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
LJSK210264
Jul 2, 2026Bard 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
LJSK201452
Jul 2, 2026Bard 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
LJSK180548
Jul 2, 2026Bard 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
LJSK102159
Jul 2, 2026Bard 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
LJSK091324
Jun 13, 2026ARROW 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
LJSK042126
K112896 +4
Feb 13, 2026Bard Peripheral Vascular Inc
Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060
Open, Classified
LJSK830233
K830256
Apr 16, 2025Bard 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
LJSK210264
Aug 16, 2024Argon Medical Devices, Inc
L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539
Open, Classified
LJSK230669
Oct 13, 2023Access Vascular, Inc
HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
Open, Classified
LJSK213550
Oct 13, 2023Access Vascular, Inc
HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002
Open, Classified
LJSK213550
Oct 5, 2023ARROW 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
LJSK160925
Oct 5, 2023ARROW 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
LJSK153487
Sep 15, 2023ARROW 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
LJSK121941
Sep 15, 2023ARROW INTERNATIONAL Inc.
Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular
Open, Classified
LJSK073451
May 18, 2023Access Vascular, Inc
HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004
Open, Classified
LJSK193015
Feb 1, 2023Bard 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
LJSK830406
K871998
Nov 8, 2022Access Vascular, Inc.
Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter
Terminated
LJSK193015
May 19, 2021Bard 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
LJSNone listed
May 19, 2021Bard Access Systems Inc.
5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with Microintroducer
Terminated
LJSK051672
Apr 7, 2021Bard 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
LJSK063240
K201452
Apr 7, 2021Bard 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
LJSK063240
K201452
Apr 7, 2021Bard 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
LJSK063240
K201452
Apr 7, 2021Bard 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
LJSK063240
K201452
Apr 7, 2021Bard 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
LJSK063240
K201452
Apr 7, 2021Bard 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
LJSK063240
K201452
Apr 7, 2021Bard 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
LJSK063240
K201452
Apr 7, 2021Bard 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
LJSK063240
K201452
Apr 7, 2021Bard 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
LJSK063240
K201452
Apr 7, 2021Bard 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
LJSK063240
K201452
Apr 7, 2021Bard 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
LJSK063240
K201452
Apr 7, 2021Bard 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
LJSK063240
K201452
Apr 7, 2021Bard 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
LJSK063240
K201452
Apr 7, 2021Bard 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
LJSK063240
K201452
Apr 7, 2021Bard 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
LJSK063240
K201452
Apr 7, 2021Bard 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
LJSK063240
K201452
Apr 7, 2021Bard 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
LJSK063240
K201452
Apr 7, 2021Bard 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
LJSK063240
K201452
May 4, 2020Angiodynamics, 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
LJSNone listed
May 4, 2020Angiodynamics, 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
LJSNone listed
Feb 26, 2020Becton Dickinson & Company
BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000435
Terminated
LJSK091324
Feb 26, 2020Becton Dickinson & Company
BARD MYPICC KIT 4F Dual-Lumen, Catalog Number CK000418B
Terminated
LJSK102159
Feb 26, 2020Becton Dickinson & Company
BARD MYPICC KIT 3F Single-Lumen, Catalog Number CK000417B
Terminated
LJSK102159
Feb 26, 2020Becton Dickinson & Company
BARD MYPICC KIT 5F Triple-Lumen, Catalog Number CK000278
Terminated
LJSK091324
Feb 26, 2020Becton Dickinson & Company
BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000277
Terminated
LJSK091324
Feb 26, 2020Becton Dickinson & Company
BARD MYPICC KIT 4F Single-Lumen, Catalog Number CK000276
Terminated
LJSK091324
Feb 26, 2020Becton Dickinson & Company
BARD MYPICC KIT 5F Triple-Lumen, Catalog Number CK000026A
Terminated
LJSK091324
Feb 26, 2020Becton Dickinson & Company
BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000025
Terminated
LJSK091324

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