Cleared Traditional

Crossing Support Catheter

K183305 · Tractus Vascular, LLC · Cardiovascular
Aug 2019
Decision
250d
Days
Class 2
Risk

About This 510(k) Submission

K183305 is an FDA 510(k) clearance for the Crossing Support Catheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Tractus Vascular, LLC (Eatontown, US). The FDA issued a Cleared decision on August 5, 2019, 250 days after receiving the submission on November 28, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K183305 FDA.gov
FDA Decision Cleared SESE
Date Received November 28, 2018
Decision Date August 05, 2019
Days to Decision 250 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