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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 K180986
Device Name XableCath Support Catheter Product Family
Applicant
XableCath, Inc.
417 South Wakara Way, Suite 3510
Salt Lake City,  UT  84108 -1457
Applicant Contact Rick Gaykowski
Correspondent
XableCath, Inc.
417 South Wakara Way, Suite 3510
Salt Lake City,  UT  84108 -1457
Correspondent Contact Rick Gaykowski
Regulation Number870.1250
Classification Product Code
DQY  
Date Received04/16/2018
Decision Date 05/15/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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