Cleared Traditional

FLU-VEN TK-2

K791130 · Venospital, Inc. · Hematology
Sep 1979
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K791130 is an FDA 510(k) clearance for the FLU-VEN TK-2, a Set, Transfer (blood/plasma) (Class II — Special Controls, product code KSB), submitted by Venospital, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 4, 1979, 78 days after receiving the submission on June 18, 1979. This device falls under the Hematology review panel. Regulated under 21 CFR 864.9875.

Submission Details

510(k) Number K791130 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 1979
Decision Date September 04, 1979
Days to Decision 78 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code KSB — Set, Transfer (blood/plasma)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.9875