Cleared Traditional

K790077 - BIOSTIL # 3884
(FDA 510(k) Clearance)

K790077 · Venospital, Inc. · General Hospital

Apr 1979

Decision

109d

Days

Class 2

Risk

K790077 is an FDA 510(k) clearance for the BIOSTIL # 3884, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Venospital, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 30, 1979, 109 days after receiving the submission on January 11, 1979. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K790077 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 11, 1979
Decision Date	April 30, 1979
Days to Decision	109 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—