Identity
- Trade Name
- DLP® FDA UDI
- Generic Name
- Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage FDA UDI
- Device Name
- CANNULA 58521 FEMORAL VEN 21FR 4PK 17L FDA UDI
- Model / Reference
- 58521 FDA UDI
- Description
- CANNULA 58521 FEMORAL VEN 21FR 4PK 17L FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20613994556763 FDA UDI
- 510(k) Number
- K875353 FDA UDI
- FDA Product Code
- DWF FDA UDI
- GMDN Term
- Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 21.0 French FDA UDI
Category: Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
Dlp® by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage.
- Venous Cannula — SORIN GROUP ITALIA SRL · Class II
- Venous cardiopulmonary bypass cannula — LivaNova USA, Inc. · Class II
- Thin-Flex Single Stage Venous Drainage Cannula — Edwards Lifesciences LLC · Class II
- Venous cardiopulmonary bypass cannula — LivaNova USA, Inc. · Class II
- Venous cardiopulmonary bypass cannula — LivaNova USA, Inc. · Class II
- Paediatric Venous Cannula — SORIN GROUP ITALIA SRL · Class II
- Venous Cannula — SORIN GROUP ITALIA SRL · Class II
- Venous cardiopulmonary bypass cannula — LivaNova USA, Inc. · Class II
Cleared under the same submission
K875353 also covers:
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
- Medtronic, Inc.
Sources (1)
- FDA UDI 776725e0-688b-4280-8af0-b7caf508e9df 36 fields · synced May 30, 2026