Cleared Traditional

Cardio Flow Peripheral Guide Wire

K213834 · Cardio Flow Inc., · Cardiovascular
Mar 2022
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K213834 is an FDA 510(k) clearance for the Cardio Flow Peripheral Guide Wire, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Cardio Flow Inc., (Mahtomedi, US). The FDA issued a Cleared decision on March 18, 2022, 99 days after receiving the submission on December 9, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K213834 FDA.gov
FDA Decision Cleared SESE
Date Received December 09, 2021
Decision Date March 18, 2022
Days to Decision 99 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQX — Wire, Guide, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1330

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