Cleared Traditional

L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS

K081489 · Peter Lazic GmbH · Neurology

Sep 2008

Decision

120d

Days

Class 2

Risk

About This 510(k) Submission

K081489 is an FDA 510(k) clearance for the L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS, a Clip, Aneurysm (Class II — Special Controls, product code HCH), submitted by Peter Lazic GmbH (M?hlheim An Der Donau, DE). The FDA issued a Cleared decision on September 25, 2008, 120 days after receiving the submission on May 28, 2008. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5200.

Submission Details

510(k) Number	K081489 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 28, 2008
Decision Date	September 25, 2008
Days to Decision	120 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF