510(k) K201452 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Groshong NXT PICC Catheter
| Applicant | C.R. Bard, Inc., Salt Lake Ciy, UT, US |
| Decision | Substantially Equivalent, Mar 12, 2021 |
| Received | Jun 1, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201452
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.