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FDA 510(k)

WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500

K-Number: K101647 · 2010-08-06

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

Device Summary

WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500 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 K101647. 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 5F GUIDEWIRE SUPPORT CATHETER, MODE W500?

WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500 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 K101647.

When did WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500 receive FDA 510(k) clearance?

WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500 received FDA 510(k) clearance on 2010-08-06, under 510(k) number K101647.

Who is the listed applicant for WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500?

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 5F GUIDEWIRE SUPPORT CATHETER, MODE W500?

The FDA product code for WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500 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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