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FDA 510(k)

Digital Indeflator INFLANTE

K-Number: K260035 · 2026-09-04

ApplicantUAB Telemedicina
Decision Date2026-09-04
Product CodeMAV
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Digital Indeflator INFLANTE is the device name listed in this FDA 510(k) record. The listed applicant is UAB Telemedicina. It received FDA 510(k) clearance on 2026-09-04 under 510(k) number K260035. The device is classified under product code MAV. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Digital Indeflator INFLANTE?

Digital Indeflator INFLANTE is a medical device that received FDA 510(k) clearance on 2026-09-04. The listed applicant is UAB Telemedicina. The 510(k) number is K260035.

When did Digital Indeflator INFLANTE receive FDA 510(k) clearance?

Digital Indeflator INFLANTE received FDA 510(k) clearance on 2026-09-04, under 510(k) number K260035.

Who is the listed applicant for Digital Indeflator INFLANTE?

The FDA 510(k) record lists UAB Telemedicina as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Digital Indeflator INFLANTE?

The FDA product code for Digital Indeflator INFLANTE is MAV.

Related Devices (Code: MAV)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220773Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P)Medtronic VascularK162272Fluent inflation deviceVascular Solutions, Inc.K153038Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival KitMedtronic, Inc.K153672basixTOUCH40 Inflation SyringeMerit Medical Systems, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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