Cleared Traditional

FLU-VEN 01510

K790424 · Venospital, Inc. · General Hospital
Apr 1979
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K790424 is an FDA 510(k) clearance for the FLU-VEN 01510, 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, 60 days after receiving the submission on March 1, 1979. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K790424 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 1979
Decision Date April 30, 1979
Days to Decision 60 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FPA — Set, Administration, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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