AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS— 510(k) K964238

Name: FDA 510(k) clearance K964238
Creator: U.S. Food and Drug Administration
Published: 1997-09-08

Substantially Equivalent

Aircast, Inc.

FDA 510(k) clearance K964238 for AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS, Substantially Equivalent on 1997-09-08. Applicant: Aircast, Inc.. Device class: 2.

Clearance details

Applicant: Aircast, Inc.
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 1996-10-23
Decision date: 1997-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Summit, NJ, US

Download summary PDF View on FDA.gov ↗

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More clearances from Aircast, Inc.

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K024019 — ARTERIALFLOW SYSTEM, MODEL 32A2003-06-03
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K992454 — VENAFLOW SYSTEM, MODEL 30A2000-01-13
K961676 — AIRCAST VENAFLOW SYSTEM (MODIFICATION)1997-03-28
K933977 — AIRCAST EDEMAFLOW SYSTEM1993-12-07

Recalls naming K964238

K-number listed on FDA's recall record

Z-1985-2019 — Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC.Class II·Ongoing·DJO, LLC·20190117

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K964238.

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