Asahi Corsair Armet 18
The ASAHI Corsair Armet 18 is a microcatheter that supports guidewire placement and exchange in peripheral blood vessels. It can also assist delivery of contrast medium into the peripheral…
The ASAHI Corsair Armet 18 is a microcatheter that supports guidewire placement and exchange in peripheral blood vessels. It can also assist delivery of contrast medium into the peripheral vasculature.
The device consists of a distal tip, shaft tube, protector and connector. A hydrophilic coating covers the outside of the tip and distal shaft, and the radiopaque tip helps identify the distal end during imaging.
Use Limits
The microcatheter is intended for single use and is sterilized with ethylene oxide. It is intended for peripheral procedures and must not be used in coronary or neurovascular vessels.
Who Else Makes It
Concentrated in Shanghai (5), Jiangsu (5), Guangdong (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Covidien Medical Products (Shanghai) Manufacturing LLC | Shanghai | Shanghai | Contract manufacturer | 8 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
| OrbusNeich Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Complaint-file establishment | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Shanghai Wallaby Medical Technologies Co., Inc. | Shanghai | Shanghai | Contract manufacturer | 5 |
| DK Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Showing 12 of 14. All 14 manufacturers in China registered for Catheter, Percutaneous
Record
| Listed by | Asahi Intecc Co., Ltd., Japan |
|---|---|
| FDA product code | DQY |
| Device type | Catheter, Percutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K202252 |
| Record published | 2020-09-25 |
| Record revised | 2022-01-25 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Catheter gauge 2.2 Fr; length 60 to 135 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CSAR110-18N | Catheter Gauge 2.2 Fr | In distribution |
| CSAR090-18N | Length 90 cm | In distribution |
| CSAR060-18N | Catheter Gauge 2.2 Fr | In distribution |
| CSAR135-18N | Length 135 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Launcher™ | Medtronic, Inc. | 3,805 |
| Sherpa NX Balanced™ | Medtronic, Inc. | 1,523 |
| Arrow | Teleflex Medical LLC | 1,249 |
| Z2 | Medtronic, Inc. | 955 |
| Vista Brite TIP | Cordis Corp. | 789 |
| Mach1™ | Boston Scientific Corporation | 777 |
| Sherpa NX Active | Medtronic, Inc. | 571 |
| Zuma® | Medtronic, Inc. | 569 |
| Convey | Pendracare International B.V. | 532 |
| Taiga | Medtronic, Inc. | 307 |
| RunWay™ | Boston Scientific Corporation | 300 |
| ConcierGE Guiding Excellence™ | Merit Medical Systems, Inc. | 295 |
Showing 12 of 500. All products under Catheter, Percutaneous
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241158 | 2024-06-25 |
| K202252 | 2020-09-08 |
| K192782 | 2019-11-29 |
| K182844 | 2019-06-22 |
| K182420 | 2018-12-20 |
| K161126 | 2016-08-25 |
| K161362 | 2016-06-14 |
| K152249 | 2016-03-04 |
| K152447 | 2016-01-22 |
| K151103 | 2015-06-23 |
| K141981 | 2015-03-09 |
| K132556 | 2013-10-24 |
| K091188 | 2010-02-26 |
| K083127 | 2009-02-03 |
| K072316 | 2007-09-17 |
| K062885 | 2007-06-13 |
| K061601 | 2006-11-17 |
| K060745 | 2006-06-23 |
| K051772 | 2005-09-26 |
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.