ADVANTA SUPER SOFT GRAFT— 510(k) K000504

Substantially Equivalent

Atrium Medical Corp.

FDA 510(k) clearance K000504 for ADVANTA SUPER SOFT GRAFT, Substantially Equivalent on 2000-03-01. 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: 2000-02-15
Decision date: 2000-03-01
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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K121070 — C-QUR RPM MESH2012-04-26
K113112 — CLEARWAY RX NB CATHETER2011-11-17
K102596 — ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT2010-10-05

Recalls naming K000504

K-number listed on FDA's recall record

Z-2312-2013 — Advanta SuperSoft 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 K000504.

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