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FDA 510(k)

WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)]

K-Number: K121382 · 2012-12-06

ApplicantWestmed, Inc.
Decision Date2012-12-06
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)] is the device name listed in this FDA 510(k) record. The listed applicant is Westmed, Inc.. It received FDA 510(k) clearance on 2012-12-06 under 510(k) number K121382. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)]?

WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)] is a medical device that received FDA 510(k) clearance on 2012-12-06. The listed applicant is Westmed, Inc.. The 510(k) number is K121382.

When did WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)] receive FDA 510(k) clearance?

WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)] received FDA 510(k) clearance on 2012-12-06, under 510(k) number K121382.

Who is the listed applicant for WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)]?

The FDA 510(k) record lists Westmed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)]?

The FDA product code for WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)] is CAH.

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Official Source

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