Cleared Traditional

DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY

K101497 · Oscor, Inc. · Cardiovascular

Oct 2010

Decision

141d

Days

Class 2

Risk

About This 510(k) Submission

K101497 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 October 20, 2010, 141 days after receiving the submission on June 1, 2010. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number	K101497 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 01, 2010
Decision Date	October 20, 2010
Days to Decision	141 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF