Identity
- Trade Name
- ATS SIMULUS® FDA UDI
- Generic Name
- Mitral/tricuspid annuloplasty ring, open-surgery FDA UDI
- Device Name
- RING SIM SR 800SR38 SEMI-RIGID 38MM FDA UDI
- Model / Reference
- 800SR38 FDA UDI
- Description
- RING SIM SR 800SR38 SEMI-RIGID 38MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169301047 FDA UDI
- 510(k) Number
- K072655 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
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 38.0 Millimeter FDA UDI
Category: Mitral/tricuspid annuloplasty ring, open-surgery
Ats Simulus® 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
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- 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
K072655 also covers:
- ATS SIMULUS® — MEDTRONIC, INC.
- ATS SIMULUS® — MEDTRONIC, INC.
- ATS Tri-Ad® — MEDTRONIC, INC.
- ATS Tri-Ad® — MEDTRONIC, INC.
- ATS Tri-Ad® — MEDTRONIC, INC.
- ATS Tri-Ad® — MEDTRONIC, INC.
- Simulus™ — MEDTRONIC, INC.
- Simulus™ — MEDTRONIC, INC.
- Simulus™ — MEDTRONIC, INC.
- Simulus™ — MEDTRONIC, INC.
- Simulus™ — MEDTRONIC, INC.
- Simulus™ — 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 07b6cea1-00a1-448f-bba5-2f3d2612871a 37 fields · synced May 30, 2026