GUIDE WIRE

Wire, Guide, Catheter

DATASCOPE CORP.

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

Pre-market Notification Details

Device IDK870664
510k NumberK870664
Device Name:GUIDE WIRE
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 Received1987-02-19
Decision Date1987-03-25

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