Cleared Special

5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter

K230156 · Medtronic Vascular · Cardiovascular
Jun 2023
Decision
162d
Days
Class 2
Risk

About This 510(k) Submission

K230156 is an FDA 510(k) clearance for the 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Medtronic Vascular (Danvers, US). The FDA issued a Cleared decision on June 30, 2023, 162 days after receiving the submission on January 19, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K230156 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 2023
Decision Date June 30, 2023
Days to Decision 162 days
Submission Type Special
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

More from Medtronic Vascular

View all
Steerant? Super Stiff Guidewire
K232570 · DQX · Oct 2023
6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter
K232190 · DQY · Aug 2023
Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P)
K220773 · MAV · Apr 2022
Medtronic 6F Taiga Guiding Catheter
K192296 · DQY · Sep 2019
Admiral Xtreme
K173515 · LIT · Apr 2018