Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit
FDA 510(k) K153038 · Medtronic, Inc.
510(k) numberK153038
Submission
- Device name
- Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit
- Applicant
- Medtronic, Inc.
Danvers, MA, US - Received
- October 19, 2015
- Decision date
- April 13, 2016
- Decision
- Unknown (SESK)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAV – Syringe, Balloon Inflation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1650
- Specialty
- Cardiovascular
Other 510(k)s with product code MAV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260035 | Digital Indeflator INFLANTEMAV · Traditional | UAB Telemedicina | 09/04/2026SE |
| K220773 | Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and…MAV · Special | Medtronic Vascular | 04/13/2022SE |
| K162272 | Fluent inflation deviceMAV · Special | Vascular Solutions, Inc. | 10/20/2016SE |
| K153672 | basixTOUCH40 Inflation SyringeMAV · Special | Merit Medical Systems, Inc. | 01/20/2016SESK |
| K152387 | Fluent Inflation DeviceMAV · Traditional | Vascular Solutions, Inc. | 12/18/2015SESK |
| K140943 | Mastro Plus Balloon In-Deflation DeviceMAV · Traditional | Beijing Demax Medical Technology Co.,Ltd | 03/05/2015SE |
| K143522 | Presto Inflation DeviceMAV · Traditional | C.R. Bard, Inc. | 01/12/2015SE |
| K133795 | Summed Inflation Device KitMAV · Traditional | Sunny Medical Device (Shenzhen) Co., Ltd. | 12/12/2014SE |
| K140745 | Encore 26 Advantage KitMAV · Special | Boston Scientific Corp | 04/17/2014SESK |
| K130566 | BasixtouchMAV · Special | Merit Medical Systems, Inc. | 06/19/2013SE |
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Questions and answers
When was Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit cleared by the FDA?
Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit (K153038) received a 510(k) decision of Unknown on April 13, 2016, 177 days after the submission was received.
What is the product code of K153038?
The FDA product code is MAV – Syringe, Balloon Inflation, a Class II (moderate risk) device regulated under 21 CFR 870.1650.