BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER

Catheter, Percutaneous

BRIDGEPOINT MEDICAL

The following data is part of a premarket notification filed by Bridgepoint Medical with the FDA for Bridgepoint Medical Mantaray(tm) Catheter.

Pre-market Notification Details

Device IDK111963
510k NumberK111963
Device Name:BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER
ClassificationCatheter, Percutaneous
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 CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-07-11
Decision Date2011-08-10
Summary:summary

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