Identity
- Trade Name
- RAP Femoral Venous Cannula FDA UDI
- Generic Name
- Cardiopulmonary bypass cannula, femoral FDA UDI
- Model / Reference
- 200-100J FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00803622147210 FDA UDI
- 510(k) Number
- K052081 FDA UDI
- FDA Product Code
- DWF FDA UDI
- GMDN Term
- Cardiopulmonary bypass cannula, femoral FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4210 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiopulmonary bypass cannula, femoral
RAP Femoral Venous Cannula by LivaNova USA, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary bypass cannula, femoral.
- Venous Femoral Cannula — SORIN GROUP ITALIA SRL · Class II
- Fem-Flex II Femoral Arterial Cannula — Edwards Lifesciences LLC · Class II
- Fem-Flex II Femoral Arterial Cannula — Edwards Lifesciences LLC · Class II
- Fem-Flex II Femoral Arterial Cannula — Edwards Lifesciences LLC · Class II
- Arterial Femoral Cannula — SORIN GROUP ITALIA SRL · Class II
- Fem-Flex Femoral Arterial Cannula — Edwards Lifesciences LLC · Class II
- Fem-Flex II Femoral Arterial Cannula — Edwards Lifesciences LLC · Class II
- Fem-Flex Femoral Arterial Cannula — Edwards Lifesciences LLC · Class II
Cleared under the same submission
K052081 also covers:
- FlexFlow Venous Cannula — LivaNova USA, Inc.
- FlexFlow Venous Cannula — LivaNova USA, Inc.
- FlexFlow Venous Cannula — LivaNova USA, Inc.
- RAP Femoral Venous Cannula — LivaNova USA, Inc.
- RAP Femoral Venous Cannula — LivaNova USA, Inc.
- RAP Femoral Venous Cannula — LivaNova USA, Inc.
- RAP Femoral Venous Cannula — LivaNova USA, Inc.
- RAP Femoral Venous Cannula — LivaNova USA, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- LivaNova USA, Inc.
Sources (1)
- FDA UDI fd0aa30e-8cb2-463d-a5e8-d61c93973300 33 fields · synced Jun 8, 2026