CAVH/CVVH/CAVHD SET MODEL #HT-HF/505

Set, Tubing, Blood, With And Without Anti-regurgitation Valve

HAEMOTRONIC, INC.

The following data is part of a premarket notification filed by Haemotronic, Inc. with the FDA for Cavh/cvvh/cavhd Set Model #ht-hf/505.

Pre-market Notification Details

Device IDK921597
510k NumberK921597
Device Name:CAVH/CVVH/CAVHD SET MODEL #HT-HF/505
ClassificationSet, Tubing, Blood, With And Without Anti-regurgitation Valve
Applicant HAEMOTRONIC, INC. 45 KULICK RD. Fairfield,  NJ  07004
ContactWiller Ghelfi
CorrespondentWiller Ghelfi
HAEMOTRONIC, INC. 45 KULICK RD. Fairfield,  NJ  07004
Product CodeFJK  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-04-03
Decision Date1995-02-24

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