FDA 510(k) Applications for Medical Device Product Code "MAV"
(Syringe, Balloon Inflation)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K961471 | ADVANCED CARDIOVASCULAR SYSTEMS, INC. | INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE) | 05/08/1996 |
| K962495 | ADVANCED CARDIOVASCULAR SYSTEMS, INC. | INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE) | 09/12/1996 |
| K060643 | ATRION MEDICAL PRODUCTS, INC. | QL LOCKING SYRINGE | 07/12/2006 |
| K140943 | BEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD. | MASTRO PLUS BALLOON IN-DEFLATION DEVICE | 03/05/2015 |
| K120694 | BOSTON SCIENTIFIC CORP. | ENCORE 26 ADVANTAGE KIT | 04/03/2012 |
| K123214 | BOSTON SCIENTIFIC CORP. | ENCORE 26 ADVANTAGE KIT | 11/13/2012 |
| K140745 | BOSTON SCIENTIFIC CORP. | ENCORE 26 ADVANTAGE KIT | 04/17/2014 |
| K143522 | C.R. BARD, INC. | Presto Inflation Device | 01/12/2015 |
| K220773 | Medtronic Vascular | 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 | 04/13/2022 |
| K153038 | MEDTRONIC, INC. | Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit | 04/13/2016 |
| K960983 | MEDTRONICS INTERVENTIONAL VASCULAR | MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT | 05/30/1996 |
| K122321 | MERIT MEDICAL IRELAND, LTD. | BASIXCONPAK ANALOG INFLATION SYRINGE | 12/19/2012 |
| K130566 | MERIT MEDICAL SYSTEMS, INC. | BASIXTOUCH | 06/19/2013 |
| K153672 | MERIT MEDICAL SYSTEMS, INC. | basixTOUCH40 Inflation Syringe | 01/20/2016 |
| K993341 | MERIT MEDICAL SYSTEMS, INC. | INTELLISYSTEM II COLOR MONITOR | 10/25/1999 |
| K040138 | MERIT MEDICAL SYSTEMS, INC. | VICEROY INFLATION DEVICE | 02/13/2004 |
| K953676 | NAMIC | BREEZE DIGITAL INFLATION DEVICE | 03/29/1996 |
| K122152 | OXTI CORPORATION | OXTI INFLATION DEVICE | 12/14/2012 |
| K953522 | RYDER INTL. CORP. | USCI IDEAL PTCA KIT | 04/17/1996 |
| K955869 | SCIMED LIFE SYSTEMS, INC. | SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE | 03/22/1996 |
| K082755 | SEDAT | SEDAT FLAMINGO | 12/15/2008 |
| K042449 | SEDAT S.A. | DOLPHIN INFLATION DEVICE | 04/18/2005 |
| K170027 | SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD. | Inflation Device | 10/06/2017 |
| K102648 | SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD | ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK | 07/01/2011 |
| K133795 | SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD | SUMMED INFLATION DEVICE KIT | 12/12/2014 |
| K012480 | VANGUARD MEDICAL CONCEPTS, INC. | VANGUARD REPROCESSED INFLATION DEVICES | 01/22/2002 |
| K152387 | VASCULAR SOLUTIONS, INC. | Fluent Inflation Device | 12/18/2015 |
| K162272 | VASCULAR SOLUTIONS, INC. | Fluent inflation device | 10/20/2016 |
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