Cleared Traditional

Wingman 18 Crossing Catheter

K160848 · Reflow Medical, Inc. · Cardiovascular
Jul 2016
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K160848 is an FDA 510(k) clearance for the Wingman 18 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 July 14, 2016, 108 days after receiving the submission on March 28, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K160848 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2016
Decision Date July 14, 2016
Days to Decision 108 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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