510(k) K193015 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
HydroPICC (PICC-142)
| Applicant | Access Vascular, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, Feb 20, 2020 |
| Received | Oct 29, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193015
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 18, 2023 | Access Vascular, Inc HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004 Open, Classified |
LJS | None listed |
| Feb 10, 2023 | Access Vascular, Inc HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002 Open, Classified |
FOZ | None listed |
| Feb 10, 2023 | Access Vascular, Inc HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001 Open, Classified |
FOZ | None listed |
| Nov 8, 2022 | Access Vascular, Inc. Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter Terminated |
LJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.