BIGBOSS CATHETER

Catheter, Percutaneous

BRIDGEPOINT MEDICAL

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

Pre-market Notification Details

Device IDK113589
510k NumberK113589
Device Name:BIGBOSS CATHETER
ClassificationCatheter, Percutaneous
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 CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-05
Decision Date2012-01-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00821684073759 K113589 000
00821684073742 K113589 000

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