Identity
- Trade Name
- Bio-Medicus® FDA UDI
- Generic Name
- Mitral/tricuspid annuloplasty ring, open-surgery FDA UDI
- Device Name
- CANNULA 96670-015 BIO-MEDICUS 15FR EA FDA UDI
- Model / Reference
- 96670-015 FDA UDI
- Description
- CANNULA 96670-015 BIO-MEDICUS 15FR EA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994504586 FDA UDI
- 510(k) Number
- K924642 FDA UDI
- FDA Product Code
- DWF FDA UDI
- GMDN Term
- Mitral/tricuspid annuloplasty ring, open-surgery 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
Yes
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
- Length — 50.0 Centimeter FDA UDICatheter Gauge — 15.0 French FDA UDI
Category: Mitral/tricuspid annuloplasty ring, open-surgery
Bio-Medicus® by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mitral/tricuspid annuloplasty ring, open-surgery.
- CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH HOLDER - MITRAL — Edwards Lifesciences LLC · Class II
- Séguin™ — ST. JUDE MEDICAL, INC. · Class II
- SJM Tailor™ — ST. JUDE MEDICAL, INC. · Class II
- Memo 4D — CORCYM SRL · Class II
- CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING — Edwards Lifesciences LLC · Class II
- Memo 4D — CORCYM SRL · Class II
- CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING — Edwards Lifesciences LLC · Class II
- CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH HOLDER - MITRAL — Edwards Lifesciences LLC · Class II
Cleared under the same submission
K924642 also covers:
- Bio-Medicus® — MEDTRONIC, INC.
- Bio-Medicus® — MEDTRONIC, INC.
- Bio-Medicus® — MEDTRONIC, INC.
- Bio-Medicus® — MEDTRONIC, INC.
- Bio-Medicus® — MEDTRONIC, INC.
- Bio-Medicus® — MEDTRONIC, INC.
- Bio-Medicus® — MEDTRONIC, INC.
- Bio-Medicus® — MEDTRONIC, INC.
- Bio-Medicus™ — MEDTRONIC, INC.
- Bio-Medicus™ — MEDTRONIC, INC.
- Bio-Medicus™ — MEDTRONIC, INC.
- Bio-Medicus™ — 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 f71f1831-614f-4aa1-ac6f-e35d4d8ca358 37 fields · synced May 30, 2026