Encore 26 Advantage Kit
FDA 510(k) K140745 · Boston Scientific Corp
510(k) numberK140745
Submission
- Device name
- Encore 26 Advantage Kit
- Applicant
- Boston Scientific Corp
Maple Grove, MN, US - Received
- March 25, 2014
- Decision date
- April 17, 2014
- 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
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|---|---|---|---|
| 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 |
| K153038 | Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable…MAV · Special | Medtronic, Inc. | 04/13/2016SESK |
| 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 |
| K130566 | BasixtouchMAV · Special | Merit Medical Systems, Inc. | 06/19/2013SE |
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Questions and answers
When was Encore 26 Advantage Kit cleared by the FDA?
Encore 26 Advantage Kit (K140745) received a 510(k) decision of Unknown on April 17, 2014, 23 days after the submission was received.
What is the product code of K140745?
The FDA product code is MAV – Syringe, Balloon Inflation, a Class II (moderate risk) device regulated under 21 CFR 870.1650.