Cleared Traditional

CLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMP

K902444 · Intramed Laboratories, Inc. · General Hospital

Aug 1990

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K902444 is an FDA 510(k) clearance for the CLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMP, a Withdrawal/infusion Pump (Class II — Special Controls, product code DQI), submitted by Intramed Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on August 30, 1990, 90 days after receiving the submission on June 1, 1990. This device falls under the General Hospital review panel. Regulated under 21 CFR 870.1800.

Submission Details

510(k) Number	K902444 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 01, 1990
Decision Date	August 30, 1990
Days to Decision	90 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—