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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter for crossing total occlusions
510(k) Number K120533
Models M-4000 AND M-4001, M-5000 AND M-5001, M-6000, M-6001, M6002, M-6003
Device Name BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES
Original Applicant
BRIDGEPOINT MEDICAL
13355 10th ave n,
suite #110
plymouth,  MN  55441
Original Contact jill munsinger
Regulation Number870.1250
Classification Product Code
PDU  
Date Received02/22/2012
Decision Date 05/22/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Clinical Trials NCT01246505
Reviewed by Third Party No
Expedited Review No
Combination Product No
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