510(k) clearance

Digital Indeflator INFLANTE

FDA 510(k) source

510(k) number

K260035

Applicant

UAB Telemedicina

Decision date

Sep 4, 2026

Date received

Jan 6, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

MAV

Device type

Syringe, Balloon Inflation

Device class

Class II

Regulation

21 CFR 870.1650

Advisory committee

Cardiovascular

Statement or summary

Summary

Third party

N

Location

Kaunas, LT