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)
Top companies in MAV
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 5, 2025 | Boston Scientific Corporation Boston Scientific Encore Advantage Kit, Material Numbers (UPN):
1. H74904527011;
2. H74904527052.
(Interventional Cardiology and Peripheral Interventions) Open, Classified |
MAV | K140745 |
| Dec 20, 2024 | Abbott Vascular Inc 20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures. Open, Classified |
MAV | K961471 |
| Dec 20, 2024 | Abbott Vascular Inc 20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures. Open, Classified |
MAV | K961471 |
| Dec 20, 2024 | Abbott 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 |
MAV | K961471 |
| Dec 20, 2024 | Abbott 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 |
MAV | K961471 |
| Mar 11, 2022 | Abbott 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 |
MAV | K962495 |
| Mar 11, 2022 | Abbott Vascular INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01) Open, Classified |
MAV | K962495 |
| Mar 11, 2022 | Abbott Vascular 20/30 Priority Pack w/COPILOT - REF 1003327 WPL2122272-01 (2019-03-01) Open, Classified |
MAV | K961471 |
| Mar 11, 2022 | Abbott 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 |
MAV | K961471 |
| Mar 11, 2022 | Abbott Vascular 20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01) Open, Classified |
MAV | K961471 |
| Jul 3, 2018 | Abbott 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 |
MAV | K962495 |
| Jun 15, 2017 | Boston Scientific Corporation Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001151050, (c) M00566670, (d) M0067101140 Terminated |
MAV | K955869 |
| Jun 7, 2017 | DeRoyal 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 |
MAV | K042449 |
| Apr 12, 2017 | Vascular 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 |
MAV | K042449 |
| Apr 5, 2017 | PEROUSE MEDICAL DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND; INTERNAL CODE NUMBER: 0185TR- 0185NA- 018SND 0185NA 0185ND Terminated |
MAV | K042449 |
| Aug 25, 2016 | Merit Medical Systems, Inc. Merit Inflation Syringe Kit. Catalog Number KOS-02857 Terminated |
MAV | K122321 |
| Dec 29, 2014 | PEROUSE 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 |
MAV | K110604 |
| Dec 29, 2014 | PEROUSE 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 |
MAV | K042449 |
| Jul 22, 2014 | Perouse Medical Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter. Terminated |
MAV | K082755 |
| Feb 26, 2014 | Medtronic 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 |
MAV | K942269 |
| Aug 25, 2010 | Medtronic, Inc. Medtronic Everest 30 Disposable Inflation Device, AC3205P.
Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon. Terminated |
MAV | K942269 K960983 |
| Aug 25, 2010 | Medtronic, Inc. Medtronic Everest 30 Disposable Inflation Device, AC3200.
Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon. Terminated |
MAV | K942269 K960983 |
| Aug 25, 2010 | Medtronic, Inc. Medtronic Everest 20 Disposable Inflation Device, AC2200.
Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon. Terminated |
MAV | K942269 K960983 |
| Jan 6, 2006 | Merit Medical Systems, Inc IntelliSystem II Thermal Dot Matrix printer 220 V 50 Hz adapter and fiber optic serial interface 10m cable. Terminated |
MAV | K993341 |
| Jan 6, 2006 | Merit Medical Systems, Inc IntelliSystem II Thermal Dot Matrix printer 220 V 50 Hz adapter and fiber optic serial interface 10m cable. Terminated |
MAV | K993341 |
| Jan 6, 2006 | Merit Medical Systems, Inc IntelliSystem II Thermal Dot Matrix printer 110 V adapter and fiber optic serial interface 10m cable Terminated |
MAV | K993341 |
| Jan 6, 2006 | Merit Medical Systems, Inc IntelliSystem II Thermal Dot Matrix printer 110 V adapter and fiber optic serial interface 10m cable Terminated |
MAV | K993341 |
| Dec 17, 2005 | Merit Medical Systems, Inc Viceroy Inflation Syringe, 60mL, without gauge. Terminated |
MAV | K040138 |
| Dec 17, 2005 | Merit Medical Systems, Inc Viceroy Inflation Syringe, 60mL, Sterile, Rx only. Terminated |
MAV | K040138 |
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