Cleared Traditional

DIALY-NATE SET & DIALY-NATE CATHETER

K872221 · Gesco Intl., Inc. · Gastroenterology & Urology

Oct 1987

Decision

126d

Days

Class 2

Risk

About This 510(k) Submission

K872221 is an FDA 510(k) clearance for the DIALY-NATE SET & DIALY-NATE CATHETER, a Catheter, Peritoneal Dialysis, Single Use (Class II — Special Controls, product code FKO), submitted by Gesco Intl., Inc. (San Antonio, US). The FDA issued a Cleared decision on October 13, 1987, 126 days after receiving the submission on June 9, 1987. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.

Submission Details

510(k) Number	K872221 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 09, 1987
Decision Date	October 13, 1987
Days to Decision	126 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	—