Cleared Traditional

DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY

K122958 · Oscor, Inc. · Cardiovascular
Dec 2012
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K122958 is an FDA 510(k) clearance for the DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on December 13, 2012, 79 days after receiving the submission on September 25, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K122958 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 2012
Decision Date December 13, 2012
Days to Decision 79 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