ClearanceBrief
Panels › Cardiovascular › Product code MAV · Class 2

Syringe, Balloon Inflation

Regulation 870.1650

1510(k)s in 12 months (58 all time)
0recalls in 12 months (29 all time)
29recalls that name a 510(k)
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Top companies in MAV

DateFirm and productCodeLinked 510(k)
Sep 5, 2025Boston Scientific Corporation
Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H74904527011; 2. H74904527052. (Interventional Cardiology and Peripheral Interventions)
Open, Classified
MAVK140745
Dec 20, 2024Abbott Vascular Inc
20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures.
Open, Classified
MAVK961471
Dec 20, 2024Abbott Vascular Inc
20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures.
Open, Classified
MAVK961471
Dec 20, 2024Abbott Vascular Inc
20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherect
Open, Classified
MAVK961471
Dec 20, 2024Abbott Vascular Inc
20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such as balloon dilatation catheters to create and monitor pressure in the balloon.
Open, Classified
MAVK961471
Mar 11, 2022Abbott Vascular
Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority Pack w/.115 RHV - REF 1000185-115 WPL2122279-01 (2019-03-01)
Open, Classified
MAVK962495
Mar 11, 2022Abbott Vascular
INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01)
Open, Classified
MAVK962495
Mar 11, 2022Abbott Vascular
20/30 Priority Pack w/COPILOT - REF 1003327 WPL2122272-01 (2019-03-01)
Open, Classified
MAVK961471
Mar 11, 2022Abbott Vascular
20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019-03-01) 20/30 Priority Pack w/.115 RHV - REF 1000186-115 WPL2122270-02 (2019-03-01)
Open, Classified
MAVK961471
Mar 11, 2022Abbott Vascular
20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)
Open, Classified
MAVK961471
Jul 3, 2018Abbott Vascular
PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters
Terminated
MAVK962495
Jun 15, 2017Boston Scientific Corporation
Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001151050, (c) M00566670, (d) M0067101140
Terminated
MAVK955869
Jun 7, 2017DeRoyal Industries Inc
DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device indicated during angioplasty procedures to inflate and deflate the balloon catheter, and control
Terminated
MAVK042449
Apr 12, 2017Vascular Solutions, Inc.
Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. DOLPHIN is a single-use, sterile inflation device used in cardiovascular procedures to pressurize (inflate) and de
Terminated
MAVK042449
Apr 5, 2017PEROUSE MEDICAL
DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND; INTERNAL CODE NUMBER: 0185TR- 0185NA- 018SND 0185NA 0185ND
Terminated
MAVK042449
Aug 25, 2016Merit Medical Systems, Inc.
Merit Inflation Syringe Kit. Catalog Number KOS-02857
Terminated
MAVK122321
Dec 29, 2014PEROUSE MEDICAL
Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional procedures, to create and monitor pressu
Terminated
MAVK110604
Dec 29, 2014PEROUSE MEDICAL
Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during cardiovascular to create and maintain, monitor pressure in the balloon catheter - balloon inflation de
Terminated
MAVK042449
Jul 22, 2014Perouse Medical
Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter.
Terminated
MAVK082755
Feb 26, 2014Medtronic Vascular
Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P The Everest 20cc Inflation device is designed to be used to inflate / deflate balloon catheters as well as to monitor
Terminated
MAVK942269
Aug 25, 2010Medtronic, Inc.
Medtronic Everest 30 Disposable Inflation Device, AC3205P. Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon.
Terminated
MAVK942269
K960983
Aug 25, 2010Medtronic, Inc.
Medtronic Everest 30 Disposable Inflation Device, AC3200. Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon.
Terminated
MAVK942269
K960983
Aug 25, 2010Medtronic, Inc.
Medtronic Everest 20 Disposable Inflation Device, AC2200. Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon.
Terminated
MAVK942269
K960983
Jan 6, 2006Merit Medical Systems, Inc
IntelliSystem II Thermal Dot Matrix printer 220 V 50 Hz adapter and fiber optic serial interface 10m cable.
Terminated
MAVK993341
Jan 6, 2006Merit Medical Systems, Inc
IntelliSystem II Thermal Dot Matrix printer 220 V 50 Hz adapter and fiber optic serial interface 10m cable.
Terminated
MAVK993341
Jan 6, 2006Merit Medical Systems, Inc
IntelliSystem II Thermal Dot Matrix printer 110 V adapter and fiber optic serial interface 10m cable
Terminated
MAVK993341
Jan 6, 2006Merit Medical Systems, Inc
IntelliSystem II Thermal Dot Matrix printer 110 V adapter and fiber optic serial interface 10m cable
Terminated
MAVK993341
Dec 17, 2005Merit Medical Systems, Inc
Viceroy Inflation Syringe, 60mL, without gauge.
Terminated
MAVK040138
Dec 17, 2005Merit Medical Systems, Inc
Viceroy Inflation Syringe, 60mL, Sterile, Rx only.
Terminated
MAVK040138

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