Identity
- Trade Name
- Aortic-Root Cannula FDA UDI
- Generic Name
- Cardioplegia cannula FDA UDI
- Model / Reference
- R502-15 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08033178004008 FDA UDI
- FDA Product Code
- DWF FDA UDI
- GMDN Term
- Cardioplegia cannula 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: Cardioplegia cannula
Aortic-Root Cannula by Sorin Group Italia Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardioplegia cannula.
- Surge Cardiovascular — MED MICHIGAN HOLDINGS LLC · Class II
- Surge Cardiovascular — MED MICHIGAN HOLDINGS LLC · Class II
- DLP™ — MEDTRONIC, INC. · Class II
- Cardioplegia cannula — LivaNova USA, Inc. · Class II
- DLP® — MEDTRONIC, INC. · Class II
- Cardioplegia cannula — LivaNova USA, Inc. · Class II
- DLP® — MEDTRONIC, INC. · Class II
- MICROTEK — Microtek Medical LLC · Class II
Cleared under the same submission
K240193 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sorin Group Italia Srl
Sources (1)
- FDA UDI 49fcebac-1c7b-4dd0-be11-08b894bef299 33 fields · synced May 29, 2026