DATASCOPE PERCOR STAT INTRA-AORTIC BALLOON

System, Balloon, Intra-aortic And Control

DATASCOPE CORP.

The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Datascope Percor Stat Intra-aortic Balloon.

Pre-market Notification Details

Device IDK910997
510k NumberK910997
Device Name:DATASCOPE PERCOR STAT INTRA-AORTIC BALLOON
ClassificationSystem, Balloon, Intra-aortic And Control
Applicant DATASCOPE CORP. 3 FIR CT. P.O. BOX 3100 Oakland,  NJ  07436
ContactBill Corrigan
CorrespondentBill Corrigan
DATASCOPE CORP. 3 FIR CT. P.O. BOX 3100 Oakland,  NJ  07436
Product CodeDSP  
CFR Regulation Number870.3535 [🔎]
DecisionSubstantially Equivalent - Market After Inspection (SI)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-03-08
Decision Date1991-11-05

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