Identity
- Trade Name
- SimuPlus™ FDA UDI
- Generic Name
- Mitral/tricuspid annuloplasty ring, open-surgery FDA UDI
- Device Name
- BAND 7700FB32 SIMUPLUS FLEX 32MM US FDA UDI
- Model / Reference
- 7700FB32 FDA UDI
- Description
- BAND 7700FB32 SIMUPLUS FLEX 32MM US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000271015 FDA UDI
- 510(k) Number
- K201449 FDA UDI
- FDA Product Code
- KRH FDA UDI
- GMDN Term
- Mitral/tricuspid annuloplasty ring, open-surgery FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 32.0 Millimeter FDA UDI
Category: Mitral/tricuspid annuloplasty ring, open-surgery
The SimuPlus Flex 32MM US device is a mitral/tricuspid annuloplasty ring designed to support insufficient and/or stenotic mitral or tricuspid valves during open heart surgery. This circular band provides a secure and adjustable fit, allowing for optimal implantation with sutures or anchors. Developed by MEDTRONIC, INC., the SimuPlus Flex 32MM US is available in various sizes and is intended for use as a single-use replacement device.
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
K201449 also covers:
- SimuForm™ — MEDTRONIC, INC.
- SimuForm™ — MEDTRONIC, INC.
- SimuForm™ — MEDTRONIC, INC.
- SimuForm™ — MEDTRONIC, INC.
- SimuForm™ — MEDTRONIC, INC.
- SimuForm™ — MEDTRONIC, INC.
- SimuForm™ — MEDTRONIC, INC.
- SimuForm™ — MEDTRONIC, INC.
- SimuForm™ — MEDTRONIC, INC.
- SimuForm™ — MEDTRONIC, INC.
- SimuForm™ — MEDTRONIC, INC.
- SimuForm™ — MEDTRONIC, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
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 907c676a-46f6-4bfe-8e41-26835bde65b3 37 fields · synced Jul 21, 2026