Cleared Traditional

TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM

K961707 · Sorenson Critical Care · Anesthesiology

Mar 1997

Decision

313d

Days

Class 1

Risk

About This 510(k) Submission

K961707 is an FDA 510(k) clearance for the TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM, a Catheters, Suction, Tracheobronchial (Class I — General Controls, product code BSY), submitted by Sorenson Critical Care (Salt Lake City, US). The FDA issued a Cleared decision on March 11, 1997, 313 days after receiving the submission on May 2, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.6810.

Submission Details

510(k) Number	K961707 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 02, 1996
Decision Date	March 11, 1997
Days to Decision	313 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement