Cleared Traditional

Cordis BRITECROSS Support Catheter

K233637 · Cordis US Corp · Cardiovascular
Jun 2024
Decision
228d
Days
Class 2
Risk

About This 510(k) Submission

K233637 is an FDA 510(k) clearance for the Cordis BRITECROSS Support Catheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Cordis US Corp (Miami Lakes, US). The FDA issued a Cleared decision on June 28, 2024, 228 days after receiving the submission on November 13, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K233637 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2023
Decision Date June 28, 2024
Days to Decision 228 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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