Cleared Special

K112579 - WILDCAT 5F GUIDEWIRE SUPPORT CATHETER

K112579 is an FDA 510(k) clearance for WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, manufactured by Avinger, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Special 510(k) pathway after a 30-day FDA review.

K112579 · Avinger, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
30d
Days
Class 2
Risk

K112579 is an FDA 510(k) clearance for the WILDCAT 5F GUIDEWIRE SUPPORT CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Avinger, Inc. (Redwood City, US). The FDA issued a Cleared decision on October 6, 2011 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Avinger, Inc. devices

FDA 510(k) Submission Details - K112579

510(k) Number K112579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2011
Decision Date October 06, 2011
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQY Catheter, Percutaneous

All 780
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K112579.
8FR TURBO - TANDEM SYSTEM
K112032 · Spectranetics Corp. · Oct 2011
BANTAM CATHETER (280MM BALLOON LENGTHS)
K112335 · ClearStream Technologies , Ltd. · Oct 2011
ONSET ACCESS CATHETER SYSTEM
K112629 · Onset Medical Corporation · Oct 2011
SELECTRA ACCESSORY KIT
K111839 · Biotronik, Inc. · Sep 2011
SELECTRA SLITTER TOOL
K112482 · Biotronik, Inc. · Sep 2011
THE UNBALLOON NON-OCCLUSIVE CATHETER
K110891 · LeMaitre Vascular, Inc. · Sep 2011