VASOSTAT HEMOSTASIS DEVICE

Clamp, Vascular

FORGE MEDICAL INC.

The following data is part of a premarket notification filed by Forge Medical Inc. with the FDA for Vasostat Hemostasis Device.

Pre-market Notification Details

Device IDK123041
510k NumberK123041
Device Name:VASOSTAT HEMOSTASIS DEVICE
ClassificationClamp, Vascular
Applicant FORGE MEDICAL INC. 150 LEVINBERG LANE Wayne,  NJ  07470
ContactMason Diamond
CorrespondentMason Diamond
FORGE MEDICAL INC. 150 LEVINBERG LANE Wayne,  NJ  07470
Product CodeDXC  
CFR Regulation Number870.4450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-09-28
Decision Date2013-05-29
Summary:summary

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