AIR-BAND RADIAL COMPRESSION DEVICE

Clamp, Vascular

DATASCOPE CORP., CARDIAC ASSIST DIVISION

The following data is part of a premarket notification filed by Datascope Corp., Cardiac Assist Division with the FDA for Air-band Radial Compression Device.

Pre-market Notification Details

Device IDK122405
510k NumberK122405
Device Name:AIR-BAND RADIAL COMPRESSION DEVICE
ClassificationClamp, Vascular
Applicant DATASCOPE CORP., CARDIAC ASSIST DIVISION 15 LAW DR. Fairfield,  NJ  07004 -0011
ContactCarla S Cerqueira
CorrespondentCarla S Cerqueira
DATASCOPE CORP., CARDIAC ASSIST DIVISION 15 LAW DR. Fairfield,  NJ  07004 -0011
Product CodeDXC  
CFR Regulation Number870.4450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-07
Decision Date2012-11-09
Summary:summary

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