Encore™ 26 Advantage Kit
Inflation Device Kit
6manufacturers in China registered for this device type
1catalogue number
5510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1), Fujian (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Forefront (Xiamen) Medical Devices Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 8 |
| Tianjin Demax Medical Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Beijing Demax Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 5 |
| Shenzhen Antmed Co., Ltd. | Dongguan | Guangdong | Manufacturer | 4 |
Record
| Listed by | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | MAV |
| Device type | Syringe, Balloon Inflation |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1650 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2020-05-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| H74904527011 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Demax | Beijing Demax Medical Technology Co., Ltd. | 18 |
| Everest™ | Medtronic, Inc. | 16 |
| basixCOMPAK™ | Merit Medical Systems, Inc. | 16 |
| QL Disposable Inflation Device | Atrion Medical Products, Inc. | 15 |
| basixTOUCH™ | Merit Medical Systems, Inc. | 12 |
| Fluent™ inflation device | Vascular Solutions LLC | 10 |
| Indeflator | Abbott Vascular | 6 |
| DeRoyal | Deroyal Industries, Inc. | 4 |
| QL Locking Syringe Device | Atrion Medical Products, Inc. | 4 |
| QL® Inflation Device | Atrion Medical Products, Inc. | 4 |
| Sphere™ Inflation Device | Atrion Medical Products, Inc. | 3 |
| Medex | ICU Medical, Inc | 3 |
Showing 12 of 39. All products under Syringe, Balloon Inflation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K140745 | 2014-04-17 |
| K123214 | 2012-11-13 |
| K120694 | 2012-04-03 |
| K922573 | 1992-12-08 |
| K904394 | 1990-12-03 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Boston Scientific Corporation | UDI-DI | 2025-08-05 | Class II | Under Investigation by firm | The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate | 68347 units |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-06-15 | Class II | Under Investigation by firm | Boston Scientific (BSC) has received complaints for cracked trays on the Encore device. | 305,779 units | 2020-07-22 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.