Cleared Special

K073100 - INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S (FDA 510(k) Clearance)

K073100 · Oscor, Inc. · Cardiovascular device

Nov 2007

Decision

28d

Days

Class 2

Risk

K073100 is an FDA 510(k) clearance for the INTRODUCER SETS, MODELS 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 November 30, 2007, 28 days after receiving the submission on November 2, 2007.

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

Submission Details

510(k) Number	K073100 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 02, 2007
Decision Date	November 30, 2007
Days to Decision	28 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Statement