Cleared Traditional

K070865 - EXPANDING VASCULAR SHEATH (FDA 510(k) Clearance)

K070865 · Applied Medical · Cardiovascular device

Oct 2007

Decision

208d

Days

Class 2

Risk

K070865 is an FDA 510(k) clearance for the EXPANDING VASCULAR SHEATH. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).

Submitted by Applied Medical (Rancho Santa, US). The FDA issued a Cleared decision on October 23, 2007, 208 days after receiving the submission on March 29, 2007.

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

Submission Details

510(k) Number	K070865 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 29, 2007
Decision Date	October 23, 2007
Days to Decision	208 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF