Identity
- Trade Name
- HAART FDA UDI
- Generic Name
- Aortic annuloplasty ring FDA UDI
- Device Name
- Aortic Annuloplasty Ring FDA UDI
- Model / Reference
- 300-23US FDA UDI
- Description
- Aortic Annuloplasty Ring FDA UDI
Identifiers
- Catalog Number
- 300-23US FDA UDI
- Primary DI / UDI-DI
- 10857160006291 FDA UDI
- 510(k) Number
- K163608 FDA UDI
- FDA Product Code
- PST FDA UDI
- GMDN Term
- Aortic annuloplasty ring 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Aortic annuloplasty ring
Haart by Corcym Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Aortic annuloplasty ring.
- HAART — Corcym Inc. · Class II
- HAART — Corcym Inc. · Class II
- HAART — Corcym Inc. · Class II
- HAART — Corcym Inc. · Class II
- HAART — Corcym Inc. · Class II
- HAART — Corcym Inc. · Class II
- HAART — Corcym Inc. · Class II
Cleared under the same submission
K163608 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Corcym Inc.
Sources (1)
- FDA UDI 5cf9ac14-5fa0-4e02-b7ae-1f8bf8a763b5 36 fields · synced May 30, 2026