510(k) K170027
- Device
- Inflation Device
- Applicant
- SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD.
- 510(k) number
- K170027
- Product code
- MAV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-10-06
- Date received
- 2017-01-03
- Regulation
- 870.1650
- Classification name
- Syringe, Balloon Inflation
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Clearance type
- Traditional
- Third party reviewed
- No
Other 510(k) Records For Product Code MAV #
| 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 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 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 |
Legacy Summary#
summary
FDA Review#
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