510(k) K160941 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter
| Applicant | Brosmed Medical Co., Ltd., Dongguan, CN |
| Decision | Substantially Equivalent, Dec 13, 2016 |
| Received | Apr 4, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160941
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 14, 2018 | BrosMed Medical Co.,Ltd. Hermes NC PTA Balloon Dilatation Catheter
The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the Terminated |
LIT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.