ADVANTA GRAFT— 510(k) K992441

Substantially Equivalent

Atrium Medical Corp.

FDA 510(k) clearance K992441 for ADVANTA GRAFT, Substantially Equivalent on 1999-08-20. Applicant: Atrium Medical Corp.. Device class: 2.

Clearance details

Applicant: Atrium Medical Corp.
Product code: Code DYF
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

Download summary PDF View on FDA.gov ↗

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K984183 — PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 314511999-02-01

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Recalls naming K992441

K-number listed on FDA's recall record

Z-2309-2013 — Advanta VS 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 K992441.

Data sourced from openFDA. This site is unofficial and independent of the FDA.