Cleared Traditional

Wingman 35 Crossing Catheter

K173661 · Reflow Medical, Inc. · Cardiovascular
Apr 2018
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K173661 is an FDA 510(k) clearance for the Wingman 35 Crossing Catheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Reflow Medical, Inc. (San Clemente, US). The FDA issued a Cleared decision on April 18, 2018, 140 days after receiving the submission on November 29, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K173661 FDA.gov
FDA Decision Cleared SESE
Date Received November 29, 2017
Decision Date April 18, 2018
Days to Decision 140 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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