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Distal Perfusion Catheter
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 2105-15M510(k) K032041
Identity
- Device Name
- Distal Perfusion Catheter EUDAMED
- Model / Reference
- 2105-15M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840663112180 EUDAMED
- Basic UDI-DI
- 08406631DPCT8 EUDAMED
- 510(k) Number
- K032041 FDA 510(k)
- FDA Product Code
- DWF FDA 510(k)
- EMDN Code
- C0104020103 VASCULAR OCCLUSION CATHETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4210 FDA 510(k)
- Regulation Number
- 870.4210 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Distal Perfusion Catheter by LeMaitre Vascular, Inc. — Class IIa — FDA_510K, MDR — 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/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K032041 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 08406631DPCT8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- LeMaitre Vascular, Inc.
- EUDAMED SRN
- US-MF-000016778
- Authorised Representative
- LeMaitre Vascular GmbH DE-AR-000013539
Sources (2)
- EUDAMED 08cb60a0-5572-47eb-97ab-ee40ac6da4ec 61 fields · synced Aug 3, 2026
- FDA 510(k) K032041 24 fields · synced May 18, 2026