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Penumbra System (Reperfusion Catheter RED 72)
FDA 510(k)Class II (US FDA 510(k))
510(k) K211654
Identifiers
- 510(k) Number
- K211654 FDA 510(k)
- FDA Product Code
- NRY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Penumbra System (Reperfusion Catheter RED 72) is a medical device used for reperfusion in acute ischemic stroke, designed to restore blood flow to the brain.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211654 | Class II | Active |
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Manufacturer
- Manufacturer
- Penumbra, Inc.
Sources (1)
- FDA 510(k) K211654 24 fields · synced Jul 30, 2026