MANTARAY GUIDEWIRES

Wire, Guide, Catheter

BRIDGEPOINT MEDICAL

The following data is part of a premarket notification filed by Bridgepoint Medical with the FDA for Mantaray Guidewires.

Pre-market Notification Details

Device IDK120881
510k NumberK120881
Device Name:MANTARAY GUIDEWIRES
ClassificationWire, Guide, Catheter
Applicant BRIDGEPOINT MEDICAL 13355 10TH AVE N, SUITE #110 Plymouth,  MN  55441
ContactJill Munsinger
CorrespondentJill Munsinger
BRIDGEPOINT MEDICAL 13355 10TH AVE N, SUITE #110 Plymouth,  MN  55441
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-03-23
Decision Date2012-04-18
Summary:summary

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