Cleared Traditional

K802122 - CLIRANS TH13 HOLLOW FIBER DIALYZER
(FDA 510(k) Clearance)

K802122 · Terumo America, Inc. · Gastroenterology & Urology

Dec 1980

Decision

105d

Days

Class 2

Risk

K802122 is an FDA 510(k) clearance for the CLIRANS TH13 HOLLOW FIBER DIALYZER, a Dialyzer, Capillary, Hollow Fiber (Class II — Special Controls, product code FJI), submitted by Terumo America, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 18, 1980, 105 days after receiving the submission on September 4, 1980. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number	K802122 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 04, 1980
Decision Date	December 18, 1980
Days to Decision	105 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	—