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Impella CP Introducer Kit
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 0052-3052/0052-0038, 0052-3053/0052-0039Model 0052-3052, 0052-3053, 0052-3046510(k) K192769
by Abiomed Inc.
Identity
- Device Name
- Impella CP Introducer Kit EUDAMED
- Model / Reference
- 0052-3052, 0052-3053, 0052-3046 EUDAMED0052-3052/0052-0038, 0052-3053/0052-0039 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00813502011685 EUDAMED
- Basic UDI-DI
- B-00813502011685 EUDAMED
- EMDN Code
- C0502 CARDIOVASCULAR INTRODUCER SHEATHS, VALVED EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
Category: Vascular catheter introduction set, nonimplantable
Impella CP Introducer Kit by Abiomed, Inc. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Also classified as Vascular catheter introduction set, nonimplantable.
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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 | K192769 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00813502011685 | Class IIa | 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 d5d44b08-7847-417a-a59c-209e7dc7572a 85 fields · synced Jul 14, 2026
- EUDAMED d5d44b08-7847-417a-a59c-209e7dc7572a-1 61 fields · synced Jun 9, 2026
- FDA 510(k) K192769 1 fields · synced May 18, 2026