FLEXMEDICS GUIDEWIRE .012 ONLY

Wire, Guide, Catheter

FLEXMEDICS

The following data is part of a premarket notification filed by Flexmedics with the FDA for Flexmedics Guidewire .012 Only.

Pre-market Notification Details

Device IDK895899
510k NumberK895899
Device Name:FLEXMEDICS GUIDEWIRE .012 ONLY
ClassificationWire, Guide, Catheter
Applicant FLEXMEDICS 6470 RIVERVIEW TERRACE Minneapolis,  MN  55432
ContactConstance G Bundy
CorrespondentConstance G Bundy
FLEXMEDICS 6470 RIVERVIEW TERRACE Minneapolis,  MN  55432
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-10-06
Decision Date1990-05-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00821684058091 K895899 000
00821684058084 K895899 000
20763000185835 K895899 000
20763000185828 K895899 000
10821684007041 K895899 000
10821684007034 K895899 000

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