ADVANTA GRAFT— 510(k) K992443

Clearance details

Applicant

Atrium Medical Corp.

Product code

Code DSY

Device class

Class 2

Regulation

21 CFR 870.3450

Advisory panel

Cardiovascular

Date received

1999-07-22

Decision date

1999-08-20

Decision

Substantially Equivalent

Clearance type

Special

Location

Hudson, NH, US

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• K241550 — Gelweave Vascular Prostheses2025-02-27
• K241070 — Gelsoft Plus Vascular Prostheses2024-11-15
• K231972 — Advanta VXT Vascular Graft, Flixene Vascular Graft2024-03-28

• K130131 — EDRAIN CHEST DRAINAGE SYSTEM2013-02-28
• K122138 — ATRIUM FLIXENE IFG VASCULAR GRAFT2012-08-17
• K121070 — C-QUR RPM MESH2012-04-26
• K113112 — CLEARWAY RX NB CATHETER2011-11-17
• K102596 — ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT2010-10-05

Death

29

Injury

694

Total

723

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2315-2013 — Advanta VS Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.Class II·Terminated·Atrium Medical Corporation·20130712

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K992443.