Cleared Traditional

WILDCAT 7F GUIDEWIRE SUPPORT CATHETER

K083313 · Avinger, Inc. · Cardiovascular
Feb 2009
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K083313 is an FDA 510(k) clearance for the WILDCAT 7F GUIDEWIRE SUPPORT CATHETER, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Avinger, Inc. (Redwood City, US). The FDA issued a Cleared decision on February 2, 2009, 84 days after receiving the submission on November 10, 2008. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K083313 FDA.gov
FDA Decision Cleared SESE
Date Received November 10, 2008
Decision Date February 02, 2009
Days to Decision 84 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQY — Catheter, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

Similar Devices — DQY Catheter, Percutaneous

All 885
Amplatzer? Trevisio? Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80
K260499 · Abbott Medical · Mar 2026
C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)
K253409 · Medtronic, Inc. · Dec 2025
Amplatzer Piccolo? Delivery System (9-PDS-04F-045)
K252417 · Abbott Medical · Dec 2025
Telescope Guide Extension Catheter
K252390 · Medtronic, Ireland · Oct 2025
CPS Locator 3D Delivery Catheter
K250147 · Centerpoint Systems · Aug 2025
CoraForce Microcatheter, CoraFlex Microcatheter
K251277 · Reflow Medical, Inc. · Aug 2025