510(k) K162901 ยท NRY Catheter, Thrombus Retriever
Penumbra 3D Revascularization Device
| Applicant | Penumbra, Inc., Alameda CA, US |
| Decision | Substantially Equivalent, Apr 20, 2017 |
| Received | Oct 17, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162901
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 22, 2017 | Penumbra Inc. Penumbra 3D Revascularization Device
It is indicated for used in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the inte Terminated |
NRY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.