Identity
- Trade Name
- MiAR™ Aortic Root Cannula with Flow-Guard™ FDA UDI
- Generic Name
- Cardioplegia cannula FDA UDI
- Device Name
- CANNULA 11012L AR FLOWGUARD LNG 12GA 10P FDA UDI
- Model / Reference
- 11012L FDA UDI
- Description
- CANNULA 11012L AR FLOWGUARD LNG 12GA 10P FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20613994495468 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
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 — 9.0 French FDA UDI
Category: Cardioplegia cannula
MiAR™ Aortic Root Cannula with Flow-Guard™ by Medtronic, Inc. — 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
- Cardioplegia cannula — LivaNova USA, Inc. · Class II
- Cardioplegia cannula — LivaNova USA, Inc. · Class II
- MICROTEK — Microtek Medical LLC · Class II
- Vessel Cannulae — LivaNova USA, Inc. · Class II
- Surge Cardiovascular — MED MICHIGAN HOLDINGS LLC · Class II
- Surge Cardiovascular — MED MICHIGAN HOLDINGS LLC · Class II
Cleared under the same submission
K100274 also covers:
K790565 also covers:
- DLP® — MEDTRONIC, INC.
- DLP® — MEDTRONIC, INC.
- DLP® — MEDTRONIC, INC.
- DLP® — MEDTRONIC, INC.
- DLP® — MEDTRONIC, INC.
- DLP® — MEDTRONIC, INC.
- DLP® — MEDTRONIC, INC.
- DLP® — MEDTRONIC, INC.
- DLP® — MEDTRONIC, INC.
- DLP® Aortic Root Cannula with Flow-Guard™ — MEDTRONIC, INC.
- DLP® Aortic Root Cannula with Flow-Guard™ — MEDTRONIC, INC.
- DLP™ — MEDTRONIC, 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
- Medtronic, Inc.
Sources (1)
- FDA UDI e5773492-2b02-430d-885b-fbe640c45e58 36 fields · synced May 30, 2026