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FDA 510(k)

FUSION QUATTRO EXTRACTION BALLOON XL

K-Number: K063677 · 2007-01-05

ApplicantWilson-Cook Medical, Inc.
Decision Date2007-01-05
Product CodeGCA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FUSION QUATTRO EXTRACTION BALLOON XL 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 2007-01-05 under 510(k) number K063677. 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 FUSION QUATTRO EXTRACTION BALLOON XL?

FUSION QUATTRO EXTRACTION BALLOON XL is a medical device that received FDA 510(k) clearance on 2007-01-05. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K063677.

When did FUSION QUATTRO EXTRACTION BALLOON XL receive FDA 510(k) clearance?

FUSION QUATTRO EXTRACTION BALLOON XL received FDA 510(k) clearance on 2007-01-05, under 510(k) number K063677.

Who is the listed applicant for FUSION QUATTRO EXTRACTION BALLOON XL?

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 FUSION QUATTRO EXTRACTION BALLOON XL?

The FDA product code for FUSION QUATTRO EXTRACTION BALLOON XL 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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