Syringe, Balloon Inflation
FDA product code MAV · Class II (moderate risk) · 21 CFR 870.1650 · Cardiovascular
58510(k) clearances
0PMA approvals
23recalls
Manufacturers
- Merit Medical Systems, Inc. 6
- Boston Scientific Corporation 5
- Advanced Cardiovascular Systems, Inc. 4
- Scimed Life Systems, Inc. 2
- Medtronics Interventional Vascular 2
- Vascular Solutions, Inc. 2
- Medex, Inc. 2
- Professional Medical Services 2
- Cook Urological, Inc. 1
- Everest Medical Corp. 1
- UAB Telemedicina 1
- North American Instrument Corp. 1
- Vascumed Systems 1
- Cardiovascular Diagnostic Services 1
- Scimed 1
- Argon Medical Corp. 1
- Allied Systems Co. 1
- Baxter Healthcare Corp 1
- Shiley, Inc. 1
- E.A. Fischione Instrument Mfg. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260035 | Digital Indeflator INFLANTEMAV · Traditional | UAB Telemedicina | 09/04/2026SE |
| K220773 | Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and…MAV · Special | Medtronic Vascular | 04/13/2022SE |
| K162272 | Fluent inflation deviceMAV · Special | Vascular Solutions, Inc. | 10/20/2016SE |
| K153038 | Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable…MAV · Special | Medtronic, Inc. | 04/13/2016SESK |
| K153672 | basixTOUCH40 Inflation SyringeMAV · Special | Merit Medical Systems, Inc. | 01/20/2016SESK |
| K152387 | Fluent Inflation DeviceMAV · Traditional | Vascular Solutions, Inc. | 12/18/2015SESK |
| K140943 | Mastro Plus Balloon In-Deflation DeviceMAV · Traditional | Beijing Demax Medical Technology Co.,Ltd | 03/05/2015SE |
| K143522 | Presto Inflation DeviceMAV · Traditional | C.R. Bard, Inc. | 01/12/2015SE |
| K133795 | Summed Inflation Device KitMAV · Traditional | Sunny Medical Device (Shenzhen) Co., Ltd. | 12/12/2014SE |
| K140745 | Encore 26 Advantage KitMAV · Special | Boston Scientific Corp | 04/17/2014SESK |
| K130566 | BasixtouchMAV · Special | Merit Medical Systems, Inc. | 06/19/2013SE |
| K122321 | Basixconpak Analog Inflation SyringeMAV · Traditional | Merit Medical Ireland, Ltd. | 12/19/2012SE |
| K122152 | Oxti Inflation DeviceMAV · Traditional | Oxti Corporation | 12/14/2012SE |
| K123214 | Encore 26 Advantage KitMAV · Special | Boston Scientific Corp | 11/13/2012SE |
| K120694 | Encore 26 Advantage KitMAV · Special | Boston Scientific Corp | 04/03/2012SE |
| K102648 | Ant Inflation Device/Ant Inflation Device Compact PackMAV · Traditional | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | 07/01/2011SE |
| K082755 | Sedat FlamingoMAV · Special | Sedat | 12/15/2008SE |
| K060643 | QL Locking SyringeMAV · Traditional | Atrion Medical Products, Inc. | 07/12/2006SE |
| K042449 | Dolphin Inflation DeviceMAV · Traditional | Sedat S.A. | 04/18/2005SE |
| K040138 | Viceroy Inflation DeviceMAV · Traditional | Merit Medical Systems, Inc. | 02/13/2004SE |
| K012480 | Vanguard Reprocessed Inflation DevicesMAV · Traditional | Vanguard Medical Concepts, Inc. | 01/22/2002SE |
| K993341 | Intellisystem II Color MonitorMAV · Special | Merit Medical Systems, Inc. | 10/25/1999SE |
| K962495 | Indeflator Plus 30/PLUS 30 Priority PACK9WITH THE.096 OR.115 Rotating Hemostatic Valve)MAV · Traditional | Advanced Cardiovascular Systems, Inc. | 09/12/1996SE |
| K960983 | Medtronic Everst 30 Inflation Device/Survival KitMAV · Traditional | Medtronics Interventional Vascular | 05/30/1996SE |
| K961471 | Indeflator 20/30 Inflation Device and 20/30 Priority Pack (with the .096 or .115…MAV · Traditional | Advanced Cardiovascular Systems, Inc. | 05/08/1996SESK |
| K953522 | Usci Ideal Ptca KitMAV · Traditional | Ryder Intl. Corp. | 04/17/1996SE |
| K953676 | Breeze Digital Inflation DeviceMAV · Traditional | Namic | 03/29/1996SE |
| K955869 | Scimed Encore 26 Inflation Device/Encore 30 Inflation DeviceMAV · Traditional | Scimed Life Systems, Inc. | 03/22/1996SE |
| K952566 | OscilflatorMAV · Traditional | Surgical Technologies, Inc. | 08/31/1995SE |
| K943597 | Monarch Ap(Tm)MAV · Traditional | Merit Medical Systems, Inc. | 02/10/1995SE |
| K942269 | Medtronic Everest Inflation DeviceMAV · Traditional | Medtronics Interventional Vascular | 10/18/1994SE |
| K940896 | Medflator Ii(Tm) Disposable Inflation DeviceMAV · Traditional | Medex, Inc. | 08/11/1994SE |
| K940425 | Imagyn Medical Inflation Device with Non-Invasive Pressure TubingMAV · Traditional | Imagyn Medical, Inc. | 08/01/1994SE |
| K921757 | Angeion Igital AngeflatorMAV · Traditional | Angeion Corp. | 03/18/1993SE |
| K922573 | 10 and 20 CC Inflation/Deflation Devices W/GaugeMAV · Traditional | Boston Scientific Corp | 12/08/1992SE |
| K921719 | Acs Angiotrak(Tm) SystemMAV · Traditional | Advanced Cardiovascular Systems, Inc. | 08/07/1992SE |
| K913994 | Monarch(Tm) Inflation SyringeMAV · Traditional | Merit Medical Systems, Inc. | 02/04/1992SE |
| K912644 | Cordis Inflator DeviceMAV · Traditional | Cordis Corp. | 09/16/1991SE |
| K911295 | Angioplasty InflatorMAV · Traditional | Vastek | 07/12/1991SE |
| K910958 | Medflator Inflation SystemMAV · Traditional | Medex, Inc. | 07/12/1991SE |
| K912544 | Bipolar ForcepsMAV · Traditional | Everest Medical Corp. | 06/24/1991SE |
| K904508 | Condor Analog Inflation SyringeMAV · Traditional | Professional Medical Services | 04/02/1991SE |
| K910205 | LP-60 Low Pressure Inflation DeviceMAV · Traditional | Devices For Vascular Intervention, Inc. | 02/25/1991SE |
| K904954 | Condor Digital Inflation SyringeMAV · Traditional | Professional Medical Services | 01/16/1991SE |
| K904275 | Morse Balloon Inflation DeviceMAV · Traditional | North American Instrument Corp. | 01/03/1991SE |
| K903621 | MAGNUM-20 (TM) Inflation DeviceMAV · Traditional | Vascumed Systems | 12/20/1990SE |
| K904394 | Inflation/Deflation DeviceMAV · Traditional | Boston Scientific Corp | 12/03/1990SE |
| K902695 | Disposable Inflation GaugeMAV · Traditional | Cook Urological, Inc. | 12/03/1990SE |
| K903503 | Scimed Encore Inflation Device, Model SM2500MAV · Traditional | Scimed | 10/09/1990SE |
| K896849 | Acs Indeflator XXMAV · Traditional | Advanced Cardiovascular Systems, Inc. | 02/28/1990SE |
| K895511 | Catheter Balloon Dilator Pressure GaugeMAV · Traditional | Argon Medical Corp. | 02/28/1990SE |
| K896005 | Small Catheter InflatorMAV · Traditional | Allied Systems Co. | 02/26/1990SE |
| K895836 | Inflation Pro IIMAV · Traditional | Baxter Healthcare Corp | 12/20/1989SE |
| K861607 | Schneider-Shiley Inflation SyringesMAV · Traditional | Shiley, Inc. | 06/09/1986SE |
| K853136 | Model 1100 Apc(Angioplasty Pressure Controller)MAV · Traditional | E.A. Fischione Instrument Mfg. | 12/03/1985SE |
| K843448 | Scimed PM200 Inflation ManometerMAV · Traditional | Scimed Life Systems, Inc. | 10/23/1984SE |
| K832323 | Edslab Pressure GaugeMAV · Traditional | American Edwards Laboratories | 08/11/1983SE |
| K812304 | Dorros-Spring PressurizerMAV · Traditional | Cardiovascular Diagnostic Services | 10/13/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2534-2025 Class II | Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H74904527011; 2.…The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the… | Boston Scientific Corporation | 08/05/2025Open, Classified |
| Z-0733-2025 Class II | 20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures.Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer… | Abbott Vascular Inc | 11/06/2024Open, Classified |
| Z-0732-2025 Class II | 20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular…Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer… | Abbott Vascular Inc | 11/06/2024Open, Classified |
| Z-0731-2025 Class II | 20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular…Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer… | Abbott Vascular Inc | 11/06/2024Open, Classified |
| Z-0730-2025 Class II | 20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction…Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer… | Abbott Vascular Inc | 11/06/2024Open, Classified |
| Z-0925-2022 Class II | Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority…Due to an increase in complaint trend for leaks and intermittent/loose connections. | Abbott Vascular | 03/11/2022Open, Classified |
| Z-0924-2022 Class II | INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01)Due to an increase in complaint trend for leaks and intermittent/loose connections. | Abbott Vascular | 03/11/2022Open, Classified |
| Z-0923-2022 Class II | 20/30 Priority Pack w/COPILOT - REF 1003327 WPL2122272-01 (2019-03-01)Due to an increase in complaint trend for leaks and intermittent/loose connections. | Abbott Vascular | 03/11/2022Open, Classified |
| Z-0922-2022 Class II | 20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019-03-01)…Due to an increase in complaint trend for leaks and intermittent/loose connections. | Abbott Vascular | 03/11/2022Open, Classified |
| Z-0921-2022 Class II | 20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)Due to an increase in complaint trend for leaks and intermittent/loose connections. | Abbott Vascular | 03/11/2022Open, Classified |
| Z-0960-2019 Class II | PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use during…Incorrect expiration being entered for one lot. | Abbott Vascular | 07/03/2018Terminated |
| Z-3043-2017 Class II | Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001151050, (c)…Boston Scientific (BSC) has received complaints for cracked trays on the Encore device. | Boston Scientific Corporation | 06/15/2017Terminated |
| Z-2639-2017 Class II | DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an…Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise… | DeRoyal Industries Inc | 06/07/2017Terminated |
| Z-2180-2017 Class II | Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. DOLPHIN…The manufacturer of the DOLPHIN inflation device, Perouse Medical, has initiated a recall of the device due… | Vascular Solutions, Inc. | 04/12/2017Terminated |
| Z-1891-2017 Class II | DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA-…Complaints regarding broken blister. | Perouse Medical | 04/05/2017Terminated |
| Z-0002-2017 Class II | Merit Inflation Syringe Kit. Catalog Number KOS-02857Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit… | Merit Medical Systems, Inc. | 08/25/2016Terminated |
| Z-0877-2015 Class II | Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during…Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase… | Perouse Medical | 10/06/2014Terminated |
| Z-0876-2015 Class II | Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use…Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase… | Perouse Medical | 10/06/2014Terminated |
| Z-1121-2014 Class III | Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P The…Incorrect master label. | Medtronic Vascular | 02/06/2014Terminated |
| Z-2089-2014 Class II | Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular…Perouse Medical in France initiated a voluntary recall of certain batches of Perouse FLAMINGO Inflations… | Perouse Medical | 05/10/2012Terminated |
| Z-2273-2010 | Medtronic Everest 30 Disposable Inflation Device, AC3205P. Used to inflate/deflate…Product sterility may be compromised due to breach of package seal integrity. | Medtronic, Inc. | 07/16/2010Terminated |
| Z-2272-2010 | Medtronic Everest 30 Disposable Inflation Device, AC3200. Used to inflate/deflate…Product sterility may be compromised due to breach of package seal integrity. | Medtronic, Inc. | 07/16/2010Terminated |
| Z-2271-2010 | Medtronic Everest 20 Disposable Inflation Device, AC2200. Used to inflate/deflate…Product sterility may be compromised due to breach of package seal integrity. | Medtronic, Inc. | 07/16/2010Terminated |