510(k) K041468 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
PREMICATH, 1261.205
| Applicant | Vygon Corp., Norristown PA, US |
| Decision | Substantially Equivalent, Sep 9, 2004 |
| Received | Jun 2, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041468
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2005 | Vygon Corporation Premicath 28G PICC Catheter Terminated |
LJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.