Caliber
Catalogue number CL3030, listed by Perouse Medical, France, under Syringe, Balloon Inflation. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
1catalogue number
4recalls 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 | Perouse Medical, France |
|---|---|
| FDA product code | MAV |
| Device type | Syringe, Balloon Inflation |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1650 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K042449 |
| Record published | 2016-09-16 |
| Record revised | 2020-05-06 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 6 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CL3030 | 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
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 |
|---|---|---|---|---|---|---|---|
| Deroyal Industries, Inc. | 510(k) number | 2017-06-07 | Class II | Unknown/Undetermined by firm | Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility | 426 units | 2020-07-22 |
| Vascular Solutions LLC | 510(k) number | 2017-04-12 | Class II | Packaging | The manufacturer of the DOLPHIN inflation device, Perouse Medical, has initiated a recall of the device due to a potential defect in the sterile barrier. Use of affected product could pose a risk of microbial contamination, leading to infe | 4,110 | 2018-04-11 |
| Perouse Medical | 510(k) number | 2017-04-05 | Class II | Packaging change control | Complaints regarding broken blister. | 18,431 | 2021-02-01 |
| Perouse Medical | 510(k) number | 2014-10-06 | Class II | Device Design | Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure | 24821 units | 2017-03-24 |
Recalls
2 of these are 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 |
|---|---|---|---|---|---|
| 2014-10-06 | Class II | Device Design | Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure | 2184 units | 2017-03-24 |
| 2012-05-10 | Class II | Process control | Perouse Medical in France initiated a voluntary recall of certain batches of Perouse FLAMINGO Inflations Devices due to a potential water-tightness default. The potential default could cause an air entry when the plunger is positioned aroun | 2,496 units | 2014-09-09 |
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.