Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1650](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1650) → MAV — Syringe, Balloon Inflation # MAV · Syringe, Balloon Inflation _Cardiovascular · 21 CFR 870.1650 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MAV ## Overview - **Product Code:** MAV - **Device Name:** Syringe, Balloon Inflation - **Regulation:** [21 CFR 870.1650](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1650) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **3rd-party reviewable:** yes ## Special Controls *Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. ## Recent Cleared Devices (20 of 57) Showing 20 most recent of 57 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K220773](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MAV/K220773.md) | Everest 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 Vascular | Apr 13, 2022 | SESE | | [K162272](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MAV/K162272.md) | Fluent inflation device | Vascular Solutions, Inc. | Oct 20, 2016 | SESE | | [K153038](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MAV/K153038.md) | Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit | Medtronic, Inc. | Apr 13, 2016 | SESK | | [K153672](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MAV/K153672.md) | basixTOUCH40 Inflation Syringe | Merit Medical Systems, Inc. | Jan 20, 2016 | SESK | | [K152387](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MAV/K152387.md) | Fluent Inflation Device | Vascular Solutions, Inc. | Dec 18, 2015 | SESK | | [K140943](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MAV/K140943.md) | MASTRO PLUS BALLOON IN-DEFLATION DEVICE | Beijing Demax Medical Technology Co.,Ltd | Mar 5, 2015 | SESE | | [K143522](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MAV/K143522.md) | Presto Inflation Device | C.R. Bard, Inc. | Jan 12, 2015 | SESE | | [K133795](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MAV/K133795.md) | SUMMED INFLATION DEVICE KIT | Sunny Medical Device (Shenzhen) Co., Ltd. | Dec 12, 2014 | SESE | | [K140745](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MAV/K140745.md) | ENCORE 26 ADVANTAGE KIT | Boston Scientific Corp | Apr 17, 2014 | SESK | | [K130566](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MAV/K130566.md) | BASIXTOUCH | Merit Medical Systems, Inc. | Jun 19, 2013 | SESE | | [K122321](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MAV/K122321.md) | BASIXCONPAK ANALOG INFLATION SYRINGE | Merit Medical Ireland, Ltd. | Dec 19, 2012 | SESE | | [K122152](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MAV/K122152.md) | OXTI INFLATION DEVICE | Oxti Corporation | Dec 14, 2012 | SESE | | [K123214](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MAV/K123214.md) | ENCORE 26 ADVANTAGE KIT | Boston Scientific Corp | Nov 13, 2012 | SESE | | [K120694](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MAV/K120694.md) | ENCORE 26 ADVANTAGE KIT | Boston Scientific Corp | Apr 3, 2012 | SESE | | [K102648](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MAV/K102648.md) | ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | Jul 1, 2011 | SESE | | [K082755](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MAV/K082755.md) | SEDAT FLAMINGO | Sedat | Dec 15, 2008 | SESE | | [K060643](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MAV/K060643.md) | QL LOCKING SYRINGE | Atrion Medical Products, Inc. | Jul 12, 2006 | SESE | | [K042449](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MAV/K042449.md) | DOLPHIN INFLATION DEVICE | Sedat S.A. | Apr 18, 2005 | SESE | | [K040138](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MAV/K040138.md) | VICEROY INFLATION DEVICE | Merit Medical Systems, Inc. | Feb 13, 2004 | SESE | | [K012480](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MAV/K012480.md) | VANGUARD REPROCESSED INFLATION DEVICES | Vanguard Medical Concepts, Inc. | Jan 22, 2002 | SESE | ## Top Applicants - Merit Medical Systems, Inc. — 6 clearances - Boston Scientific Corp — 5 clearances - Advanced Cardiovascular Systems, Inc. — 4 clearances - Medex, Inc. — 2 clearances - Medtronics Interventional Vascular — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MAV](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MAV) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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