Cleared Special

K090114 - MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S (FDA 510(k) Clearance)

K090114 · Oscor, Inc. · Cardiovascular device

Jun 2009

Decision

134d

Days

Class 2

Risk

K090114 is an FDA 510(k) clearance for the MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S. This device is classified as 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 4, 2009, 134 days after receiving the submission on January 21, 2009.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number	K090114 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 21, 2009
Decision Date	June 04, 2009
Days to Decision	134 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Statement