Cleared Special

Breezeway II

K210627 · Oscor, Inc. · Cardiovascular
Jun 2021
Decision
93d
Days
Class 2
Risk

About This 510(k) Submission

K210627 is an FDA 510(k) clearance for the Breezeway II, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on June 3, 2021, 93 days after receiving the submission on March 2, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K210627 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 2021
Decision Date June 03, 2021
Days to Decision 93 days
Submission Type Special
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