Cleared Special

Medtronic 6F Taiga Guiding Catheter

K192296 · Medtronic Vascular · Cardiovascular
Sep 2019
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K192296 is an FDA 510(k) clearance for the Medtronic 6F Taiga Guiding Catheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Medtronic Vascular (Danvers, US). The FDA issued a Cleared decision on September 20, 2019, 28 days after receiving the submission on August 23, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K192296 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 2019
Decision Date September 20, 2019
Days to Decision 28 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

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