510(k) K243458 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guide
| Applicant | Access Vascular, Inc., Ballerica MA, US |
| Decision | Substantially Equivalent, Aug 1, 2025 |
| Received | Nov 8, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243458
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.