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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, percutaneous
510(k) Number K102725
Device Name CROSSBOSS CATHETER MODEL M-2000, STINGRAY ORIENTING BALLOON CATHETER MODEL M-1000, STINGRAY GUIDEWIRE MODEL M-3004 AND M
Applicant
BRIDGE MEDICAL, INC.
2800 CAMPUS DR
SUITE 50
PLYMOUTH,  MN  55441
Applicant Contact JILL MUNSINGER
Correspondent
BRIDGE MEDICAL, INC.
2800 CAMPUS DR
SUITE 50
PLYMOUTH,  MN  55441
Correspondent Contact JILL MUNSINGER
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
DQX  
Date Received09/21/2010
Decision Date 05/10/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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