Everest™
The filing describes the Everest 20 disposable inflation device as a sterile 20 cc device with a trigger-operated locking mechanism. The piston can be manually manipulated after that lock…
The filing describes the Everest 20 disposable inflation device as a sterile 20 cc device with a trigger-operated locking mechanism. The piston can be manually manipulated after that lock is released.
The Everest device is designed to inflate and deflate balloon catheters and monitor balloon pressure. The filing describes 20 bar and 30 bar manometer versions.
Listed Item
Inflation DEV AC3200 Everest 30 TJM
Device Components
The filing lists a high-pressure connecting tube, male rotating adapter and disposable three-way stopcock. The Survival Kit also includes a Y/TriAdapter, guidewire insertion tool and steering handle.
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 | Medtronic, Inc., 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, Manufacturer, Exporter |
| 510(k) | K153038 |
| Record published | 2018-04-27 |
| Record revised | 2022-09-22 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number |
| Storage | Special storage condition: Store accessories in a clean, cool and dark area. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AC3200 | Pressure Capacity of 30 ATM | In distribution |
| AC2200 | Pressure Capacity of 20 ATM | In distribution |
| AC2200 | Pressure Capacity of 20 ATM | In distribution |
| AC2205P | Pressure Capacity of 20 ATM | In distribution |
| AC3205P | Pressure Capacity of 30 ATM | In distribution |
| AC2205P | Pressure Capacity of 20 ATM | In distribution |
| AC3200 | Pressure Capacity of 30 ATM | In distribution |
| AC3205P | Pressure Capacity of 30 ATM | In distribution |
| AC2200 | Pressure Capacity of 20 ATM | In distribution |
| AC3205P | Pressure Capacity of 30 ATM | In distribution |
| AC2205P | Pressure Capacity of 20 ATM | In distribution |
| AC3205P | Pressure Capacity of 30 ATM | In distribution |
| AC2205P | Pressure Capacity of 20 ATM | In distribution |
| AC3200 | Pressure Capacity of 30 ATM | In distribution |
| AC3200 | Pressure Capacity of 30 ATM | In distribution |
| AC2200 | Pressure Capacity of 20 ATM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Demax | Beijing Demax Medical Technology Co., Ltd. | 18 |
| 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 |
| DiamondTOUCH™ | Merit Medical Systems, Inc. | 3 |
Showing 12 of 39. All products under Syringe, Balloon Inflation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K153038 | 2016-04-13 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medtronic Vascular | 510(k) number | 2014-02-06 | Class III | Labeling mix-ups | Incorrect master label. | 191 devices | 2014-06-02 |
| Medtronic Vascular | 510(k) number | 2010-07-16 | Not classified | Packaging process control | Product sterility may be compromised due to breach of package seal integrity. | 2,875 units | 2011-06-07 |
| Medtronic Vascular | 510(k) number | 2010-07-16 | Not classified | Packaging process control | Product sterility may be compromised due to breach of package seal integrity. | 768 units | 2011-06-07 |
| Medtronic Vascular | 510(k) number | 2010-07-16 | Not classified | Packaging process control | Product sterility may be compromised due to breach of package seal integrity. | 1,254 units | 2011-06-07 |
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.