Cleared Traditional

K980919 - ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER
(FDA 510(k) Clearance)

K980919 · Fortune Medical Instrument Corp. · Gastroenterology & Urology

Mar 1998

Decision

20d

Days

Class 2

Risk

K980919 is an FDA 510(k) clearance for the ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER, a Catheter, Retention Type, Balloon (Class II — Special Controls, product code EZL), submitted by Fortune Medical Instrument Corp. (Irvine, US). The FDA issued a Cleared decision on March 31, 1998, 20 days after receiving the submission on March 11, 1998. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number	K980919 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 11, 1998
Decision Date	March 31, 1998
Days to Decision	20 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement