Cleared Traditional

K873155 - GAMBRO BICART SYSTEM
(FDA 510(k) Clearance)

K873155 · Gambro, Inc. · Gastroenterology & Urology

Oct 1987

Decision

77d

Days

Class 2

Risk

K873155 is an FDA 510(k) clearance for the GAMBRO BICART SYSTEM. This device is classified as a System, Dialysate Delivery, Single Patient (Class II — Special Controls, product code FKP).

Submitted by Gambro, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on October 26, 1987, 77 days after receiving the submission on August 10, 1987.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number	K873155 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 10, 1987
Decision Date	October 26, 1987
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	—