Cleared Traditional

K080007 - GRADUATED ADAPTER WITH CLAVE (FDA 510(k) Clearance)

K080007 · Icu Medical, Inc. · Gastroenterology & Urology device

May 2008

Decision

132d

Days

Class 2

Risk

K080007 is an FDA 510(k) clearance for the GRADUATED ADAPTER WITH CLAVE. This device is classified as a Catheter, Straight (Class II - Special Controls, product code EZD).

Submitted by Icu Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on May 13, 2008, 132 days after receiving the submission on January 2, 2008.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number	K080007 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 02, 2008
Decision Date	May 13, 2008
Days to Decision	132 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF