Identifiers
- 510(k) Number
- K051332 FDA 510(k)
- FDA Product Code
- DSY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3450 FDA 510(k)
- Regulation Number
- 870.3450 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ADVANTA T-GRAFT is a vascular prosthesis intended for arterial vascular reconstruction, segmental bypass, and arteriovenous vascular access. It is a medical device classified under FDA device class 2 and is associated with the device name 'Prosthesis, Vascular Graft, Of 6mm And Greater Diameter'.
The device is supplied as a sterile, single-use product and is not reusable. It is not specified for MRI safety or storage conditions in the provided data. The device is authorized under FDA 510(k) clearance (K051332) and is reviewed by the Cardiovascular advisory committee.
Frequently asked questions
What is the ADVANTA T-GRAFT used for?
The ADVANTA T-GRAFT is a vascular prosthesis intended for arterial vascular reconstruction, segmental bypass, and arteriovenous vascular access procedures.
Is the ADVANTA T-GRAFT reusable?
No, the ADVANTA T-GRAFT is supplied as a sterile, single-use product and is not reusable.
What is the regulatory status of the ADVANTA T-GRAFT?
The ADVANTA T-GRAFT is authorized under FDA 510(k) clearance (K051332) and is reviewed by the Cardiovascular advisory committee.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K051332 FDA 510 (k) - ADVANTA T-GRAFT | Atrium Medical Corp., ADVANTA T-GRAFT (K051332) — FDA 510 (k) | Innolitics, ADVANTA GRAFT (<6MM) by ATRIUM MEDICAL CORP. | FDA 510 (k) Summary, Advanta SST PTFE Vascular Graft MRI Safety — Atrium Medical Corporation ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K051332 | Class II | Active |
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Manufacturer
- Manufacturer
- Atrium Medical Corp.
Sources (1)
- FDA 510(k) K051332 24 fields · synced Sep 23, 2026