ADVANTA SST GRAFT (>_6MM)— 510(k) K010516

Clearance details

Applicant

Atrium Medical Corp.

Product code

Code DSY

Device class

Class 2

Regulation

21 CFR 870.3450

Advisory panel

Cardiovascular

Date received

2001-02-22

Decision date

2001-05-18

Decision

Substantially Equivalent

Clearance type

Special

Location

Hudson, NH, US

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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-2311-2013 — Advanta SST Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.Class II·Terminated·Atrium Medical Corporation·20130712
• Z-2317-2013 — Advanta SST Grafts <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 K010516.