510(k) K970434 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
NEO-PICC
| Applicant | Klein-Baker Medical, Inc., San Antonio TX, US |
| Decision | Substantially Equivalent, Apr 1, 1997 |
| Received | Feb 5, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970434
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 8, 2005 | Arrow International Inc NeoPICC 1.9 FR Catheter. Percutaneous Implanted long term intravascular catheter. The product is shipped in cases of 5 units. Catalog numbers S1PIC1.9-S, S1PIC1.9-N, S1PIC1.9-SMK, and S1PIC1.9-C. Terminated |
LJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.