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FDA 510(k)

TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING

K-Number: K040129 · 2004-02-27

ApplicantWilson-Cook Medical, Inc.
Decision Date2004-02-27
Product CodeGCA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2004-02-27 under 510(k) number K040129. The device is classified under product code GCA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING?

TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING is a medical device that received FDA 510(k) clearance on 2004-02-27. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K040129.

When did TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING receive FDA 510(k) clearance?

TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING received FDA 510(k) clearance on 2004-02-27, under 510(k) number K040129.

Who is the listed applicant for TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING?

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

What is the FDA product code for TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING?

The FDA product code for TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING is GCA.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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