Cleared Traditional

SUCTION CATHETER

K981910 · Ni-Med, Inc. · Anesthesiology

Aug 1998

Decision

84d

Days

Class 1

Risk

About This 510(k) Submission

K981910 is an FDA 510(k) clearance for the SUCTION CATHETER, a Catheters, Suction, Tracheobronchial (Class I — General Controls, product code BSY), submitted by Ni-Med, Inc. (Farmington, US). The FDA issued a Cleared decision on August 24, 1998, 84 days after receiving the submission on June 1, 1998. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.6810.

Submission Details

510(k) Number	K981910 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 01, 1998
Decision Date	August 24, 1998
Days to Decision	84 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement