Digital Indeflator INFLANTE— 510(k) K260035
Substantially EquivalentUAB Telemedicina
FDA 510(k) clearance K260035 for Digital Indeflator INFLANTE, Substantially Equivalent on 2026-09-04. Applicant: UAB Telemedicina. Device class: 2.
Summary
UAB Telemedicina's Digital Indeflator INFLANTE is filed under MAV, balloon inflation syringes. The record doesn't give specifications.
Class II, 21 CFR 870.1650. Cardiovascular is both the classification panel and the review panel. It was a Traditional 510(k).
Telemedicina filed from Kaunas, Lithuania. Review took 241 calendar days (January 6 to September 4, 2026).
Clearance details
- Applicant
- UAB Telemedicina
- Product code
- Product code MAV
- Device class
- Class 2
- Regulation
- 21 CFR 870.1650
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kaunas, LT
Recent devices under product code MAV
view all- K220773 — Everest 20 Inflation Device and 3-way Stopcock (AC2200) +3 more
- K162272 — Fluent inflation device
- K153038 — Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit
- K153672 — basixTOUCH40 Inflation Syringe
- K152387 — Fluent Inflation Device
Adverse events under product code MAV
product code MAV- Malfunction
- 1,433
- Total
- 1,433
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.