Identifiers
- 510(k) Number
- K112892 FDA 510(k)
- FDA Product Code
- PBL FDA 510(k)
Classification
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESU FDA 510(k)
Impella 2.5 Plus Catheter by Abiomed, Inc. — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS
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 | K112892 | N/A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Abiomed, Inc.
Sources (1)
- FDA 510(k) K112892 24 fields · synced Jun 18, 2026