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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 K180797
Device Name Xcess Guiding Catheter
Applicant
Curatia Medical Co.
3227 Kifer Rd.
Santa Clara,  CA  95051
Applicant Contact Jessica Chiu
Correspondent
Jcq Consulting
11218 Zest Ct. NE
Blaine,  MN  55449
Correspondent Contact Breanne Butler
Regulation Number870.1250
Classification Product Code
DQY  
Date Received03/27/2018
Decision Date 12/14/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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