510(k) K153038
- Device
- Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit
- Applicant
- MEDTRONIC, INC.
- 510(k) number
- K153038
- Product code
- MAV
- Decision
- Substantially Equivalent - Kit (SESK)
- Decision date
- 2016-04-13
- Date received
- 2015-10-19
- Regulation
- 870.1650
- Classification name
- Syringe, Balloon Inflation
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- NISARG SHAH
- Address
- 37a Cherry Hill Dr. Danvers MA US 01923 01923
FDA Registration Numbers#
- 3007695715
- 3010131137
- 3007138831
- 3006950086
- 3005941719
- 1043729
- 1220452
- 2020394
- 3004091615
- 3033589330
- 3006942524
- 3006082230
- 9616684
- 3002807314
- 1060680
- 3004859241
- 1721676
- 1625425
- 1018470
- 3010291427
- 3012307300
- 1721504
- 3022815697
- 3007830707
- 1724474
- 3010872792
- 1000121056
- 3011137372
- 2024168
- 3007361214
- 1018233
- 3024893679
- 1526863
- 3010041511
- 3012536737
- 1820334
- 1928237
- 3007048453
- 3010149039
- 3005099803
- 3011050570
- 3015225571
- 3003898360
- 9681260
- 1644312
- 3014461810
- 2939561
- 1721686
- 3014579161
- 1054241
- 2124215
- 2011171
- 3004111573
- 3005580113
- 1043214
- 1055236
- 9610612
- 3027815
- 3030446844
- 3015309643
- 1825146
- 1047843
- 3010141307
- 1319639
Source Documents#
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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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