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FDA 510(k)

WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S

K-Number: K102022 · 2010-08-06

ApplicantAvinger, Inc.
Decision Date2010-08-06
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S is the device name listed in this FDA 510(k) record. The listed applicant is Avinger, Inc.. It received FDA 510(k) clearance on 2010-08-06 under 510(k) number K102022. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S?

WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S is a medical device that received FDA 510(k) clearance on 2010-08-06. The listed applicant is Avinger, Inc.. The 510(k) number is K102022.

When did WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S receive FDA 510(k) clearance?

WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S received FDA 510(k) clearance on 2010-08-06, under 510(k) number K102022.

Who is the listed applicant for WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S?

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

What is the FDA product code for WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S?

The FDA product code for WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S is DQY.

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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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