510(k) K103305 ยท HCG Device, Neurovascular Embolization
PENUMBRA EMBOLIZATION COIL SYSTEM
| Applicant | Penumbra, Inc., Alameda CA, US |
| Decision | Substantially Equivalent, Jan 26, 2011 |
| Received | Nov 9, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103305
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 12, 2011 | Penumbra Inc. Penumbra brand Penumbra Coil System, Penumbra Coil 400, Product is manufactured and distributed by Penumbra Inc., Alameda, CA
The Penumbra Coil System (Penumbra Coil 400 TM) is intended for the endov Terminated |
HCG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.