Cleared Traditional

K092544 - INSTRUMED VASCULAR CLAMPS
(FDA 510(k) Clearance)

K092544 · Instrumed International, Inc. · Cardiovascular

Oct 2009

Decision

68d

Days

Class 2

Risk

K092544 is an FDA 510(k) clearance for the INSTRUMED VASCULAR CLAMPS, a Clamp, Vascular (Class II — Special Controls, product code DXC), submitted by Instrumed International, Inc. (Schaumburg, US). The FDA issued a Cleared decision on October 26, 2009, 68 days after receiving the submission on August 19, 2009. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number	K092544 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 19, 2009
Decision Date	October 26, 2009
Days to Decision	68 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF