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Automated Impella Controller
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref 0042-0010-EU, 0042-0040-EUModel 0042-0010, 0042-0040510(k) K093801
by Abiomed Inc.
Identity
- Device Name
- Automated Impella Controller EUDAMED
- Model / Reference
- 0042-0010, 0042-0040 EUDAMED0042-0010-EU, 0042-0040-EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00813502010961 EUDAMED
- Basic UDI-DI
- B-00813502010961 EUDAMED
- EMDN Code
- Z12059099 VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY -OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Automated Impella Controller by Abiomed, Inc. — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K093801 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-00813502010961 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Abiomed Inc.
- EUDAMED SRN
- US-MF-000016855
- FDA Applicant
- Abiomed, Inc.
- Authorised Representative
- Abiomed Europe GmbH DE-AR-000005280
Sources (3)
- EUDAMED cbefc7e0-8ffb-4762-9e5a-b0568e22f7b8 85 fields · synced Jun 19, 2026
- EUDAMED cbefc7e0-8ffb-4762-9e5a-b0568e22f7b8-1 61 fields · synced Jun 9, 2026
- FDA 510(k) K093801 1 fields · synced May 18, 2026