Impella 5.0 Catheter Family
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K083111 FDA 510(k)
- FDA Product Code
- KFM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4360 FDA 510(k)
- Regulation Number
- 870.4360 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Impella 5.0 Catheter Family is a percutaneous, blood-pumping device classified as a non-roller type cardiopulmonary bypass pump. It is designed to provide mechanical circulatory support by delivering up to five liters per minute of blood flow, intended for placement within the left ventricle to assist cardiac function during temporary critical conditions.
This catheter-based system is intended for single-use and requires sterile handling. It is regulated under FDA 510(k) clearance and the Medical Device Directive (MDD), with a device classification of Class II. The Impella 5.0 is supplied as part of a catheter family with multiple registration numbers and is intended for use in cardiovascular settings, adhering to MRI safety guidelines for non-ferromagnetic components. Storage and usage follow manufacturer-provided instructions for temporary ventricular support.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Abiomed Impella 5.0 Manuals | ManualsLib, Impella – Wikipedia, IMPELLA 5.0 CATHETER FAMILY by ABIOMED, INC. | FDA 510 (k) Summary, ABIOMED | Impella 5.0® / LD®
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K083111 | Class II | Active |
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Manufacturer
- Manufacturer
- Abiomed, Inc.
Sources (2)
- FDA 510(k) K083111 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026