Cleared Special

Wingman 14C Crossing Catheter

K170996 · Reflow Medical, Inc. · Cardiovascular
Jun 2017
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K170996 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 June 9, 2017, 67 days after receiving the submission on April 3, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K170996 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 2017
Decision Date June 09, 2017
Days to Decision 67 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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