Cleared Special

CoraForce Microcatheter, CoraFlex Microcatheter

K251277 · Reflow Medical, Inc. · Cardiovascular
Aug 2025
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K251277 is an FDA 510(k) clearance for the CoraForce Microcatheter, CoraFlex Microcatheter, 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 August 22, 2025, 120 days after receiving the submission on April 24, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K251277 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 2025
Decision Date August 22, 2025
Days to Decision 120 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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