Cleared Special

Wingman 14C Crossing Catheter

K190393 · Reflow Medical, Inc. · Cardiovascular
May 2019
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K190393 is an FDA 510(k) clearance for the Wingman 14C 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 May 9, 2019, 79 days after receiving the submission on February 19, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K190393 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 2019
Decision Date May 09, 2019
Days to Decision 79 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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