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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Balloon Inflation
510(k) Number K260035
Device Name Digital Indeflator INFLANTE
Applicant
UAB Telemedicina
Vytauto Pr. 23
Kaunas,  LT 44352
Applicant Contact Evaldas Kalvaitis
Correspondent
UAB Telemedicina
Vytauto Pr. 23
Kaunas,  LT 44352
Correspondent Contact Evaldas Kalvaitis
Regulation Number870.1650
Classification Product Code
MAV  
Subsequent Product Code
DXT  
Date Received01/06/2026
Decision Date 09/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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