FDA.reportPublic FDA data

510(k) K922573

Device
10 And 20 Cc Inflation/deflation Devices W/gauge
Applicant
BOSTON SCIENTIFIC CORP.
510(k) number
K922573
Product code
MAV
Decision
Substantially Equivalent (SESE)
Decision date
1992-12-08
Date received
1992-06-01
Regulation
870.1650
Classification name
Syringe, Balloon Inflation
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KATHY O GOFF
Address
2710 Orchard Pkwy. San Jose CA US 95134 95134

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MAV#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K220773Everest 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)Medtronic Vascular2022-04-13
K162272Fluent inflation deviceVascular Solutions, Inc.2016-10-20
K153038Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival KitMedtronic, Inc.2016-04-13
K153672basixTOUCH40 Inflation SyringeMerit Medical Systems, Inc.2016-01-20
K152387Fluent Inflation DeviceVascular Solutions, Inc.2015-12-18
K140943MASTRO PLUS BALLOON IN-DEFLATION DEVICEBeijing Demax Medical Technology Co.,Ltd2015-03-05
K143522Presto Inflation DeviceC.R. Bard, Inc.2015-01-12
K133795SUMMED INFLATION DEVICE KITSunny Medical Device (Shenzhen) Co., Ltd.2014-12-12
K140745ENCORE 26 ADVANTAGE KITBoston Scientific Corp2014-04-17
K130566BASIXTOUCHMerit Medical Systems, Inc.2013-06-19
K122321BASIXCONPAK ANALOG INFLATION SYRINGEMerit Medical Ireland, Ltd.2012-12-19
K122152OXTI INFLATION DEVICEOxti Corporation2012-12-14
K123214ENCORE 26 ADVANTAGE KITBoston Scientific Corp2012-11-13
K120694ENCORE 26 ADVANTAGE KITBoston Scientific Corp2012-04-03
K102648ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACKShenzhen Ant Hi-Tech Industrial Co., Ltd.2011-07-01