Cleared Traditional

K935600 - TRACHEAL SUCTION CATHETER
(FDA 510(k) Clearance)

K935600 · Puritas Health Care, Inc. · Anesthesiology

May 1994

Decision

172d

Days

Class 1

Risk

K935600 is an FDA 510(k) clearance for the TRACHEAL SUCTION CATHETER, a Catheters, Suction, Tracheobronchial (Class I — General Controls, product code BSY), submitted by Puritas Health Care, Inc. (New Milford, US). The FDA issued a Cleared decision on May 10, 1994, 172 days after receiving the submission on November 19, 1993. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.6810.

Submission Details

510(k) Number	K935600 FDA.gov
FDA Decision	Cleared SESK
Date Received	November 19, 1993
Decision Date	May 10, 1994
Days to Decision	172 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement