Cleared Traditional

coraForce and coraFlex Support Catheters

K201811 · Reflow Medical, Inc. · Cardiovascular
Oct 2020
Decision
117d
Days
Class 2
Risk

About This 510(k) Submission

K201811 is an FDA 510(k) clearance for the coraForce and coraFlex Support Catheters, 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 October 26, 2020, 117 days after receiving the submission on July 1, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K201811 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2020
Decision Date October 26, 2020
Days to Decision 117 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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