MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003

Wire, Guide, Catheter

BRIDGEPOINT MEDICAL

The following data is part of a premarket notification filed by Bridgepoint Medical with the FDA for Mantaray Guidewire Model M-6000, M-6001, M-6002, M-6003.

Pre-market Notification Details

Device IDK111488
510k NumberK111488
Device Name:MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003
ClassificationWire, Guide, Catheter
Applicant BRIDGEPOINT MEDICAL 2800 CAMPUS DR STE 50 Plymouth,  MN  55441
ContactJill Munsinger
CorrespondentJill Munsinger
BRIDGEPOINT MEDICAL 2800 CAMPUS DR STE 50 Plymouth,  MN  55441
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-05-31
Decision Date2011-06-30

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