Identity
- Trade Name
- Sof-Flo Atraumatic Coronary Artery Shunt FDA UDI
- Generic Name
- Surgical intravascular shunt FDA UDI
- Device Name
- Vessel Shunt 1.00mm Tapered Tip, 12mm Shaft FDA UDI
- Model / Reference
- SHT-1210S FDA UDI
- Description
- Vessel Shunt 1.00mm Tapered Tip, 12mm Shaft FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00899054002005 FDA UDI
- 510(k) Number
- K972665 FDA UDI
- FDA Product Code
- DWF FDA UDI
- GMDN Term
- Surgical intravascular shunt 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
Yes
FDA UDI
Category: Surgical intravascular shunt
Sof-Flo Atraumatic Coronary Artery Shunt by Kdl Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical intravascular shunt.
- Axius Coronary Shunt — Maquet Cardiovascular LLC · Class II
- Flo-Thru Intraluminal Shunt® — SYNOVIS LIFE TECHNOLOGIES, INC. · Class II
- Axius Coronary Shunt — Maquet Cardiovascular LLC · Class II
- Flo-Thru Intraluminal Shunt® — SYNOVIS LIFE TECHNOLOGIES, INC. · Class II
- Axius Coronary Shunt — Maquet Cardiovascular LLC · Class II
- Axius Coronary Shunt — Maquet Cardiovascular LLC · Class II
- Flo-Thru Intraluminal Shunt® — SYNOVIS LIFE TECHNOLOGIES, INC. · Class II
- Axius Coronary Shunt — Maquet Cardiovascular LLC · Class II
Cleared under the same submission
K972665 also covers:
- Bulb Tip Coronary Artery Shunts — KDL MEDICAL, INC.
- Bulb Tip Coronary Artery Shunts — KDL MEDICAL, INC.
- Bulb Tip Coronary Artery Shunts — KDL MEDICAL, INC.
- Bulb Tip Coronary Artery Shunts — KDL MEDICAL, INC.
- Bulb Tip Coronary Artery Shunts — KDL MEDICAL, INC.
- Bulb Tip Coronary Artery Shunts — KDL MEDICAL, INC.
- Bulb Tip Coronary Artery Shunts — KDL MEDICAL, INC.
- Bulb Tip Coronary Artery Shunts — KDL MEDICAL, INC.
- Bulb Tip Coronary Artery Shunts — KDL MEDICAL, INC.
- Sof-Flo Atraumatic Coronary Artery Shunt — KDL MEDICAL, INC.
- Sof-Flo Atraumatic Coronary Artery Shunt — KDL MEDICAL, INC.
- Sof-Flo Atraumatic Coronary Artery Shunt — KDL MEDICAL, 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
- Kdl Medical, Inc.
Sources (1)
- FDA UDI 54f94f97-24a4-4586-bde7-89d4996f098c 35 fields · synced May 30, 2026