510(k) K103464 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
PACIFIC XTREME PTCA BALLOON DILATATION CATHETER
| Applicant | Medtronic, Inc., Danvers MA, US |
| Decision | Substantially Equivalent, Dec 22, 2010 |
| Received | Nov 24, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K103464
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2020 | ev3 Inc. Pacific Xtreme (PTCA Balloon Dilation Catheter) Terminated |
LIT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.