510(k) K213550 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
HydroPICC 5F Dual Lumen Catheter
| Applicant | Access Vascular, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, May 4, 2022 |
| Received | Nov 8, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213550
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 13, 2023 | Access Vascular, Inc HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002 Open, Classified |
LJS | None listed |
| Oct 13, 2023 | Access Vascular, Inc HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004 Open, Classified |
LJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.