VANGUARD REPROCESSED COMPRESSION GARMENT— 510(k) K012403

Name: FDA 510(k) clearance K012403
Creator: U.S. Food and Drug Administration
Published: 2001-10-17

Substantially Equivalent

Vanguard Medical Concepts, Inc.

FDA 510(k) clearance K012403 for VANGUARD REPROCESSED COMPRESSION GARMENT, Substantially Equivalent on 2001-10-17. Applicant: Vanguard Medical Concepts, Inc.. Device class: 2.

Clearance details

Applicant: Vanguard Medical Concepts, Inc.
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2001-07-30
Decision date: 2001-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakeland, FL, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K012403

K-number listed on FDA's recall record

Z-0272-2018 — 3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL Aircast Pos-Lock Connector. Intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation and reducing wound healing time on the calf.Class II·Terminated·Stryker Sustainability Solutions·20171201

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K012403.

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