BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES

Catheter For Crossing Total Occlusions

BRIDGEPOINT MEDICAL

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

Pre-market Notification Details

Device IDK120533
510k NumberK120533
Device Name:BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES
ClassificationCatheter For Crossing Total Occlusions
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 CodePDU  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-02-22
Decision Date2012-05-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00821684073841 K120533 000
00821684052723 K120533 000
00821684052730 K120533 000
00821684052747 K120533 000
00821684052754 K120533 000
00821684052761 K120533 000
00821684052778 K120533 000
00821684073742 K120533 000
00821684073759 K120533 000
00821684073780 K120533 000
00821684073797 K120533 000
00821684073827 K120533 000
00821684073834 K120533 000
00821684052716 K120533 000

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