Product Code: MAV FDA class 2 21 CFR 870.1650

Syringe, Balloon Inflation

Cardiovascular

The balloon inflation syringe is a cardiovascular device used to inflate and deflate balloon catheters during interventional procedures such as balloon angioplasty or valvuloplasty, providing controlled pressure delivery. It is classified as FDA Class II under 21 CFR 870.1650 within the Cardiovascular specialty, requiring 510(k) premarket clearance. The product code is MAV and the device is not implanted. Full GMP quality system requirements apply.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: MAV
Device Class: FDA class 2
Regulation Number: 870.1650
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 57 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
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)	Apr 13, 2022	Substantially Equivalent	Medtronic Vascular
K162272	Fluent inflation device	Oct 20, 2016	Substantially Equivalent	Vascular Solutions, Inc.
K153038	Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit	Apr 13, 2016	Unknown	Medtronic, Inc.
K153672	basixTOUCH40 Inflation Syringe	Jan 20, 2016	Unknown	Merit Medical Systems, Inc.
K152387	Fluent Inflation Device	Dec 18, 2015	Unknown	Vascular Solutions, Inc.
K140943	MASTRO PLUS BALLOON IN-DEFLATION DEVICE	Mar 05, 2015	Substantially Equivalent	Beijing Demax Medical Technology Co.,Ltd
K143522	Presto Inflation Device	Jan 12, 2015	Substantially Equivalent	C.R. Bard, Inc.
K133795	SUMMED INFLATION DEVICE KIT	Dec 12, 2014	Substantially Equivalent	Sunny Medical Device (Shenzhen) Co., Ltd.
K140745	ENCORE 26 ADVANTAGE KIT	Apr 17, 2014	Unknown	Boston Scientific Corp
K130566	BASIXTOUCH	Jun 19, 2013	Substantially Equivalent	Merit Medical Systems, Inc.
K122321	BASIXCONPAK ANALOG INFLATION SYRINGE	Dec 19, 2012	Substantially Equivalent	Merit Medical Ireland, Ltd.
K122152	OXTI INFLATION DEVICE	Dec 14, 2012	Substantially Equivalent	Oxti Corporation
K123214	ENCORE 26 ADVANTAGE KIT	Nov 13, 2012	Substantially Equivalent	Boston Scientific Corp
K120694	ENCORE 26 ADVANTAGE KIT	Apr 03, 2012	Substantially Equivalent	Boston Scientific Corp
K102648	ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK	Jul 01, 2011	Substantially Equivalent	Shenzhen Ant Hi-Tech Industrial Co., Ltd.
K082755	SEDAT FLAMINGO	Dec 15, 2008	Substantially Equivalent	Sedat
K060643	QL LOCKING SYRINGE	Jul 12, 2006	Substantially Equivalent	Atrion Medical Products, Inc.
K042449	DOLPHIN INFLATION DEVICE	Apr 18, 2005	Substantially Equivalent	Sedat S.A.
K040138	VICEROY INFLATION DEVICE	Feb 13, 2004	Substantially Equivalent	Merit Medical Systems, Inc.
K012480	VANGUARD REPROCESSED INFLATION DEVICES	Jan 22, 2002	Substantially Equivalent	Vanguard Medical Concepts, Inc.
K993341	INTELLISYSTEM II COLOR MONITOR	Oct 25, 1999	Substantially Equivalent	Merit Medical Systems, Inc.
K962495	INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE)	Sep 12, 1996	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K960983	MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT	May 30, 1996	Substantially Equivalent	Medtronics Interventional Vascular
K961471	INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE)	May 08, 1996	Unknown	Advanced Cardiovascular Systems, Inc.
K953522	USCI IDEAL PTCA KIT	Apr 17, 1996	Substantially Equivalent	Ryder Intl. Corp.
K953676	BREEZE DIGITAL INFLATION DEVICE	Mar 29, 1996	Substantially Equivalent	Namic
K955869	SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE	Mar 22, 1996	Substantially Equivalent	Scimed Life Systems, Inc.
K952566	OSCILFLATOR	Aug 31, 1995	Substantially Equivalent	Surgical Technologies, Inc.
K943597	MONARCH AP(TM)	Feb 10, 1995	Substantially Equivalent	Merit Medical Systems, Inc.
K942269	MEDTRONIC EVEREST INFLATION DEVICE	Oct 18, 1994	Substantially Equivalent	Medtronics Interventional Vascular
K940896	MEDFLATOR II(TM) DISPOSABLE INFLATION DEVICE	Aug 11, 1994	Substantially Equivalent	Medex, Inc.
K940425	IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING	Aug 01, 1994	Substantially Equivalent	Imagyn Medical, Inc.
K921757	ANGEION IGITAL ANGEFLATOR	Mar 18, 1993	Substantially Equivalent	Angeion Corp.
K922573	10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE	Dec 08, 1992	Substantially Equivalent	Boston Scientific Corp
K921719	ACS ANGIOTRAK(TM) SYSTEM	Aug 07, 1992	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K913994	MONARCH(TM) INFLATION SYRINGE	Feb 04, 1992	Substantially Equivalent	Merit Medical Systems, Inc.
K912644	CORDIS INFLATOR DEVICE	Sep 16, 1991	Substantially Equivalent	Cordis Corp.
K911295	ANGIOPLASTY INFLATOR	Jul 12, 1991	Substantially Equivalent	Vastek
K910958	MEDFLATOR INFLATION SYSTEM	Jul 12, 1991	Substantially Equivalent	Medex, Inc.
K912544	BIPOLAR FORCEPS	Jun 24, 1991	Substantially Equivalent	Everest Medical Corp.
K904508	CONDOR ANALOG INFLATION SYRINGE	Apr 02, 1991	Substantially Equivalent	Professional Medical Services
K910205	LP-60 LOW PRESSURE INFLATION DEVICE	Feb 25, 1991	Substantially Equivalent	Devices For Vascular Intervention, Inc.
K904954	CONDOR DIGITAL INFLATION SYRINGE	Jan 16, 1991	Substantially Equivalent	Professional Medical Services
K904275	MORSE BALLOON INFLATION DEVICE	Jan 03, 1991	Substantially Equivalent	North American Instrument Corp.
K903621	MAGNUM-20 (TM) INFLATION DEVICE	Dec 20, 1990	Substantially Equivalent	Vascumed Systems
K904394	INFLATION/DEFLATION DEVICE	Dec 03, 1990	Substantially Equivalent	Boston Scientific Corp
K902695	DISPOSABLE INFLATION GAUGE	Dec 03, 1990	Substantially Equivalent	Cook Urological, Inc.
K903503	SCIMED ENCORE INFLATION DEVICE, MODEL SM2500	Oct 09, 1990	Substantially Equivalent	Scimed
K896849	ACS INDEFLATOR XX	Feb 28, 1990	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K895511	CATHETER BALLOON DILATOR PRESSURE GAUGE	Feb 28, 1990	Substantially Equivalent	Argon Medical Corp.
K896005	SMALL CATHETER INFLATOR	Feb 26, 1990	Substantially Equivalent	Allied Systems Co.
K895836	INFLATION PRO II	Dec 20, 1989	Substantially Equivalent	Baxter Healthcare Corp
K861607	SCHNEIDER-SHILEY INFLATION SYRINGES	Jun 09, 1986	Substantially Equivalent	Shiley, Inc.
K853136	MODEL 1100 APC(ANGIOPLASTY PRESSURE CONTROLLER)	Dec 03, 1985	Substantially Equivalent	E.A. Fischione Instrument Mfg.
K843448	SCIMED PM200 INFLATION MANOMETER	Oct 23, 1984	Substantially Equivalent	Scimed Life Systems, Inc.
K832323	EDSLAB PRESSURE GAUGE	Aug 11, 1983	Substantially Equivalent	American Edwards Laboratories
K812304	DORROS-SPRING PRESSURIZER	Oct 13, 1981	Substantially Equivalent	Cardiovascular Diagnostic Services