Identity
- Trade Name
- Heartstring III System 4.3MM FDA UDI
- Generic Name
- Intravascular anastomosis occluder FDA UDI
- Device Name
- Heartstring III System 4.3MM FDA UDI
- Model / Reference
- HSK-3043 FDA UDI
- Description
- Heartstring III System 4.3MM FDA UDI
Identifiers
- Catalog Number
- HSK-3043 FDA UDI
- Primary DI / UDI-DI
- 00607567700321 FDA UDI
- 510(k) Number
- K130382 FDA UDI
- FDA Product Code
- DXC FDA UDI
- GMDN Term
- Intravascular anastomosis occluder FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4450 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
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
Dimensions & Sizes
- Size
- Outer Diameter — 4.3 Millimeter FDA UDI
Category: Intravascular anastomosis occluder
Heartstring III System 4.3MM by Maquet Cardiovascular LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intravascular anastomosis occluder.
- Flo-Rester® Disposable Internal Vessel Occluder — SYNOVIS LIFE TECHNOLOGIES, INC. · Class II
- Flo-Rester® Disposable Internal Vessel Occluder — SYNOVIS LIFE TECHNOLOGIES, INC. · Class II
- VIOLA — Vascular Graft Solutions, Ltd. · Class II
- Flo-Rester® Disposable Internal Vessel Occluder — SYNOVIS LIFE TECHNOLOGIES, INC. · Class II
- Flo-Rester® Disposable Internal Vessel Occluder — SYNOVIS LIFE TECHNOLOGIES, INC. · Class II
- Flo-Rester® Disposable Internal Vessel Occluder — SYNOVIS LIFE TECHNOLOGIES, INC. · Class II
- Flo-Rester® Disposable Internal Vessel Occluder — SYNOVIS LIFE TECHNOLOGIES, INC. · Class II
- Flo-Rester® Disposable Internal Vessel Occluder — SYNOVIS LIFE TECHNOLOGIES, INC. · Class II
Cleared under the same submission
K130382 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 |
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Manufacturer
- Manufacturer
- Maquet Cardiovascular LLC
Sources (1)
- FDA UDI 09328e8b-4597-4c7e-b18d-77676f43bcd7 37 fields · synced May 30, 2026