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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 K121763
Device Name MULTICROSS SUPPORT CATHETER
Applicant
ROXWOOD MEDICAL, INC.
150 executive park blvd, ste 3700
san francisco,  CA  94134
Contact mehrdad farhangnia
Regulation Number870.1250
Classification Product Code
DQY  
Date Received06/19/2012
Decision Date 11/27/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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