Product code MAV
- Device name
- Syringe, Balloon Inflation
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1650
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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... | Medtronic Vascular | 2022-04-13 |
| K162272 | Fluent inflation device | Vascular Solutions, Inc. | 2016-10-20 |
| K153038 | Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit | Medtronic, Inc. | 2016-04-13 |
| K153672 | basixTOUCH40 Inflation Syringe | Merit Medical Systems, Inc. | 2016-01-20 |
| K152387 | Fluent Inflation Device | Vascular Solutions, Inc. | 2015-12-18 |
| K140943 | MASTRO PLUS BALLOON IN-DEFLATION DEVICE | Beijing Demax Medical Technology Co.,Ltd | 2015-03-05 |
| K143522 | Presto Inflation Device | C.R. Bard, Inc. | 2015-01-12 |
| K133795 | SUMMED INFLATION DEVICE KIT | Sunny Medical Device (Shenzhen) Co., Ltd. | 2014-12-12 |
| K140745 | ENCORE 26 ADVANTAGE KIT | Boston Scientific Corp | 2014-04-17 |
| K130566 | BASIXTOUCH | Merit Medical Systems, Inc. | 2013-06-19 |
| K122321 | BASIXCONPAK ANALOG INFLATION SYRINGE | Merit Medical Ireland, Ltd. | 2012-12-19 |
| K122152 | OXTI INFLATION DEVICE | Oxti Corporation | 2012-12-14 |
| K123214 | ENCORE 26 ADVANTAGE KIT | Boston Scientific Corp | 2012-11-13 |
| K120694 | ENCORE 26 ADVANTAGE KIT | Boston Scientific Corp | 2012-04-03 |
| K102648 | ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | 2011-07-01 |
| K082755 | SEDAT FLAMINGO | Sedat | 2008-12-15 |
| K060643 | QL LOCKING SYRINGE | Atrion Medical Products, Inc. | 2006-07-12 |
| K042449 | DOLPHIN INFLATION DEVICE | Sedat S.A. | 2005-04-18 |
| K040138 | VICEROY INFLATION DEVICE | Merit Medical Systems, Inc. | 2004-02-13 |
| K012480 | VANGUARD REPROCESSED INFLATION DEVICES | Vanguard Medical Concepts, Inc. | 2002-01-22 |
| K993341 | INTELLISYSTEM II COLOR MONITOR | Merit Medical Systems, Inc. | 1999-10-25 |
| K962495 | INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE) | Advanced Cardiovascular Systems, Inc. | 1996-09-12 |
| K960983 | MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT | Medtronics Interventional Vascular | 1996-05-30 |
| K961471 | INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE) | Advanced Cardiovascular Systems, Inc. | 1996-05-08 |
| K953522 | USCI IDEAL PTCA KIT | Ryder Intl. Corp. | 1996-04-17 |
| K953676 | BREEZE DIGITAL INFLATION DEVICE | Namic | 1996-03-29 |
| K955869 | SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE | Scimed Life Systems, Inc. | 1996-03-22 |
| K952566 | OSCILFLATOR | Surgical Technologies, Inc. | 1995-08-31 |
| K943597 | MONARCH AP(TM) | Merit Medical Systems, Inc. | 1995-02-10 |
| K942269 | MEDTRONIC EVEREST INFLATION DEVICE | Medtronics Interventional Vascular | 1994-10-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00763000338206 | EVEREST™ | MEDTRONIC, INC. | 2022-05-27 |
| 00763000338190 | EVEREST™ | MEDTRONIC, INC. | 2022-05-27 |
| 00763000338183 | EVEREST™ | MEDTRONIC, INC. | 2022-05-27 |
| 00763000338176 | EVEREST™ | MEDTRONIC, INC. | 2022-05-27 |
| 00653405052350 | ConMed Inflation Device | ATRION MEDICAL PRODUCTS, INC. | 2019-04-25 |
| 00856877002285 | Stryker AVA/iVAS® Inflator | ATRION MEDICAL PRODUCTS, INC. | 2017-10-04 |
| 00856877002193 | TRACOE technic® Disposable Inflation Device | ATRION MEDICAL PRODUCTS, INC. | 2017-10-04 |
| 10351688507976 | Medex | ICU MEDICAL, INC. | 2016-10-19 |
| 10351688507884 | Medex | ICU MEDICAL, INC. | 2016-10-19 |
| 10351688510020 | Medex | ICU MEDICAL, INC. | 2016-10-11 |
| 08714729177029 | Encore™ 26 | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729180005 | Encore™ 26 Advantage Kit | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729183624 | Encore™ 26 | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729746737 | Alliance II | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 00827002255715 | Sphere™ Inflation Device | ATRION MEDICAL PRODUCTS, INC. | 2016-09-21 |
| 00827002310278 | Sphere™ Inflation Device | ATRION MEDICAL PRODUCTS, INC. | 2016-09-21 |
| 00827002349032 | Sphere™ Inflation Device | ATRION MEDICAL PRODUCTS, INC. | 2016-09-21 |
| 00827002462830 | Sphere™ Inflation Device | ATRION MEDICAL PRODUCTS, INC. | 2016-09-21 |
| 00827002496743 | Sphere™ Inflation Device | ATRION MEDICAL PRODUCTS, INC. | 2016-09-21 |
| 00856877002247 | Stryker Interventional Spine iVAS™ Inflator | ATRION MEDICAL PRODUCTS, INC. | 2016-09-20 |
| H965459830 | angiodynamics NAMIC Disposable Inflation Device | ATRION MEDICAL PRODUCTS, INC. | 2016-09-19 |
| 00801741095009 | PRESTO | Bard Peripheral Vascular, Inc. | 2016-09-19 |
| 00749756873185 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-12 |
| 00749756684606 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-12 |
| 00749756643672 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-12 |
| 00749756622127 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-12 |
| 00856877002063 | QL Disposable Inflation Device | ATRION MEDICAL PRODUCTS, INC. | 2016-08-29 |
| 00856877002070 | QL Disposable Inflation Device | ATRION MEDICAL PRODUCTS, INC. | 2016-08-29 |
| 00856877002209 | QL Disposable Inflation Device | ATRION MEDICAL PRODUCTS, INC. | 2016-08-29 |
| 00856877002216 | QL Disposable Inflation Device | ATRION MEDICAL PRODUCTS, INC. | 2016-08-29 |