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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K261886
Device Name VIVO (9002)
Applicant
Catheter Precision, Inc.
1670 Hwy. 160 W.
Suite 205
Fort Mill,  SC  29708
Applicant Contact Darci Diage
Correspondent
Catheter Precision, Inc.
1670 Hwy. 160 W.
Suite 205
Fort Mill,  SC  29708
Correspondent Contact Darci Diage
Regulation Number870.1425
Classification Product Code
DQK  
Date Received06/05/2026
Decision Date 10/30/2026
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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