Cleared Traditional

Brite Tip Radianz Guiding Sheath

K202167 · Cordis Corporation · Cardiovascular
Feb 2021
Decision
207d
Days
Class 2
Risk

About This 510(k) Submission

K202167 is an FDA 510(k) clearance for the Brite Tip Radianz Guiding Sheath, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Cordis Corporation (Miami Lakes, US). The FDA issued a Cleared decision on February 26, 2021, 207 days after receiving the submission on August 3, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K202167 FDA.gov
FDA Decision Cleared SESE
Date Received August 03, 2020
Decision Date February 26, 2021
Days to Decision 207 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DYB — Introducer, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1340

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