510(k) K152230 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
Ebony PTA .014 RX Pheripheral Dilatation Catheter
| Applicant | Natec Medical, Reduit, MU |
| Decision | Substantially Equivalent, Sep 3, 2015 |
| Received | Aug 7, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152230
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 11, 2016 | Us Endovascular USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter. Distributed by US Endovascular, St. Louis, MO. Terminated |
LIT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.