DATASCOPE INTERLOCK GUIDE WIRE EXTENSION

Wire, Guide, Catheter

DATASCOPE CORP.

The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Datascope Interlock Guide Wire Extension.

Pre-market Notification Details

Device IDK894318
510k NumberK894318
Device Name:DATASCOPE INTERLOCK GUIDE WIRE EXTENSION
ClassificationWire, Guide, Catheter
Applicant DATASCOPE CORP. 3 FIR CT. P.O. BOX 3100 Oakland,  NJ  07436
ContactSchneider, Phd
CorrespondentSchneider, Phd
DATASCOPE CORP. 3 FIR CT. P.O. BOX 3100 Oakland,  NJ  07436
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-07-14
Decision Date1989-10-12

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