Cleared Traditional

InTRAkit

K162097 · Medtronic Vascular · Cardiovascular
Nov 2016
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K162097 is an FDA 510(k) clearance for the InTRAkit, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Medtronic Vascular (Danvers, US). The FDA issued a Cleared decision on November 17, 2016, 111 days after receiving the submission on July 29, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K162097 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 2016
Decision Date November 17, 2016
Days to Decision 111 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DYB — Introducer, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1340

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
5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter
K230156 · DQY · Jun 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