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FDA 510(k)

WILDCAT 5F GUIDEWIRE SUPPORT CATHETER

K-Number: K112579 · 2011-10-06

ApplicantAvinger, Inc.
Decision Date2011-10-06
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WILDCAT 5F GUIDEWIRE SUPPORT CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Avinger, Inc.. It received FDA 510(k) clearance on 2011-10-06 under 510(k) number K112579. 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?

WILDCAT 5F GUIDEWIRE SUPPORT CATHETER is a medical device that received FDA 510(k) clearance on 2011-10-06. The listed applicant is Avinger, Inc.. The 510(k) number is K112579.

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

WILDCAT 5F GUIDEWIRE SUPPORT CATHETER received FDA 510(k) clearance on 2011-10-06, under 510(k) number K112579.

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

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?

The FDA product code for WILDCAT 5F GUIDEWIRE SUPPORT CATHETER 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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