MAV · Syringe, Balloon Inflation
Cardiovascular · 21 CFR 870.1650 · Class 2
Overview
| Product Code | MAV |
|---|---|
| Device Name | Syringe, Balloon Inflation |
| Regulation | 21 CFR 870.1650 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 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 | 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 | Fluent inflation device | Vascular Solutions, Inc. | Oct 20, 2016 | SESE |
| K153038 | 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 | basixTOUCH40 Inflation Syringe | Merit Medical Systems, Inc. | Jan 20, 2016 | SESK |
| K152387 | Fluent Inflation Device | Vascular Solutions, Inc. | Dec 18, 2015 | SESK |
| K140943 | MASTRO PLUS BALLOON IN-DEFLATION DEVICE | Beijing Demax Medical Technology Co.,Ltd | Mar 5, 2015 | SESE |
| K143522 | Presto Inflation Device | C.R. Bard, Inc. | Jan 12, 2015 | SESE |
| K133795 | SUMMED INFLATION DEVICE KIT | Sunny Medical Device (Shenzhen) Co., Ltd. | Dec 12, 2014 | SESE |
| K140745 | ENCORE 26 ADVANTAGE KIT | Boston Scientific Corp | Apr 17, 2014 | SESK |
| K130566 | BASIXTOUCH | Merit Medical Systems, Inc. | Jun 19, 2013 | SESE |
| K122321 | BASIXCONPAK ANALOG INFLATION SYRINGE | Merit Medical Ireland, Ltd. | Dec 19, 2012 | SESE |
| K122152 | OXTI INFLATION DEVICE | Oxti Corporation | Dec 14, 2012 | SESE |
| K123214 | ENCORE 26 ADVANTAGE KIT | Boston Scientific Corp | Nov 13, 2012 | SESE |
| K120694 | ENCORE 26 ADVANTAGE KIT | Boston Scientific Corp | Apr 3, 2012 | SESE |
| K102648 | ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | Jul 1, 2011 | SESE |
| K082755 | SEDAT FLAMINGO | Sedat | Dec 15, 2008 | SESE |
| K060643 | QL LOCKING SYRINGE | Atrion Medical Products, Inc. | Jul 12, 2006 | SESE |
| K042449 | DOLPHIN INFLATION DEVICE | Sedat S.A. | Apr 18, 2005 | SESE |
| K040138 | VICEROY INFLATION DEVICE | Merit Medical Systems, Inc. | Feb 13, 2004 | SESE |
| K012480 | 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
