Cleared Traditional

Lumax Guiding Catheter

K191163 · Cook Incorporated · Cardiovascular
Dec 2019
Decision
225d
Days
Class 2
Risk

About This 510(k) Submission

K191163 is an FDA 510(k) clearance for the Lumax Guiding Catheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on December 12, 2019, 225 days after receiving the submission on May 1, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K191163 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 2019
Decision Date December 12, 2019
Days to Decision 225 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

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