Identity
- Trade Name
- Coronary Artery Perfusion Cannula FDA UDI
- Generic Name
- Cardioplegia solution administration adaptor FDA UDI
- Device Name
- Coronary Artery Perfusion Cannula with balloon FDA UDI
- Model / Reference
- 415807 FDA UDI
- Description
- Coronary Artery Perfusion Cannula with balloon FDA UDI
Identifiers
- Catalog Number
- 415807 FDA UDI
- Primary DI / UDI-DI
- 00851321006086 FDA UDI
- 510(k) Number
- K030231 FDA UDI
- FDA Product Code
- DWF FDA UDI
- GMDN Term
- Cardioplegia solution administration adaptor 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardioplegia solution administration adaptor
Coronary Artery Perfusion Cannula by Vitalcor, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardioplegia solution administration adaptor.
- Terumo Cardiovascular Systems — MED MICHIGAN HOLDINGS LLC · Class II
- Cardioplegia solution administration adaptor — LivaNova USA, Inc. · Class II
- Surge Cardiovascular — MED MICHIGAN HOLDINGS LLC · Class II
- DLP® — MEDTRONIC, INC. · Class II
- Cardioplegia solution administration adaptor — LivaNova USA, Inc. · Class II
- Terumo Cardiovascular Systems — MED MICHIGAN HOLDINGS LLC · Class II
- DLP® — MEDTRONIC, INC. · Class II
- PERFUSION ADAPTER SET — NOVOSCI CORP. · Class II
Cleared under the same submission
K030231 also covers:
- Coronary Artery Perfusion Cannula — VITALCOR, INC
- Coronary Artery Perfusion Cannula — VITALCOR, INC
- Coronary Artery Perfusion Cannula — VITALCOR, INC
- Coronary Artery Perfusion Cannula — VITALCOR, INC
- Coronary Artery Perfusion Cannula — VITALCOR, INC.
- Coronary Artery Perfusion Cannula — VITALCOR, INC.
- Coronary Artery Perfusion Cannula — VITALCOR, INC.
- Coronary Artery Perfusion Cannula — VITALCOR, INC.
- Coronary Artery Perfusion Cannula — VITALCOR, 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
- Vitalcor, Inc
Sources (1)
- FDA UDI 9633163f-fbab-4539-b520-5102078e9cc9 36 fields · synced Jun 8, 2026