Cleared Traditional

TUBE GRIP

K922404 · Georgia Medical Products, Inc. · Cardiovascular

Nov 1992

Decision

186d

Days

Class 1

Risk

About This 510(k) Submission

K922404 is an FDA 510(k) clearance for the TUBE GRIP, a Accessory Equipment, Cardiopulmonary Bypass (Class I — General Controls, product code KRI), submitted by Georgia Medical Products, Inc. (Marietta, US). The FDA issued a Cleared decision on November 23, 1992, 186 days after receiving the submission on May 21, 1992. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4200.

Submission Details

510(k) Number	K922404 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 21, 1992
Decision Date	November 23, 1992
Days to Decision	186 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement