Cleared Traditional

SINC Support Catheter

K233350 · Reflow Medical, Inc. · Cardiovascular
Feb 2024
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K233350 is an FDA 510(k) clearance for the SINC Support 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 February 8, 2024, 132 days after receiving the submission on September 29, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K233350 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2023
Decision Date February 08, 2024
Days to Decision 132 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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