Cleared Traditional

DUAL PURPOSE CLOSED CATHETER

K982945 · Spirit Medical Systems, Inc. · Anesthesiology

Sep 1998

Decision

32d

Days

Class 1

Risk

About This 510(k) Submission

K982945 is an FDA 510(k) clearance for the DUAL PURPOSE CLOSED CATHETER, a Catheters, Suction, Tracheobronchial (Class I — General Controls, product code BSY), submitted by Spirit Medical Systems, Inc. (Parker, US). The FDA issued a Cleared decision on September 22, 1998, 32 days after receiving the submission on August 21, 1998. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.6810.

Submission Details

510(k) Number	K982945 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 21, 1998
Decision Date	September 22, 1998
Days to Decision	32 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF