Mi-Axus Catheter
The Mi-Axus 8F Guide Catheter is a single lumen, braided, variable stiffness shaft catheter designed for use in facilitating the insertion and guidance of micro catheters into a selected…
The Mi-Axus 8F Guide Catheter is a single lumen, braided, variable stiffness shaft catheter designed for use in facilitating the insertion and guidance of micro catheters into a selected blood vessel in the peripheral, coronary, or neuro vascular system. A radiopaque marker is included on the distal end. The catheter shaft has a hydrophilic coating. The proximal segment is constructed with Vestamid. The distal segment of the PEBAX is impregnated with barium sulphate for increased radiopacity.
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 | Mivi Neurovascular, Inc., United States |
|---|---|
| FDA product code | DQY |
| Device type | Catheter, Percutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| 510(k) | K151396 |
| Record published | 2017-03-15 |
| Record revised | 2021-12-22 (version 8) |
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 |
| Storage | Special storage condition: Dark and dry |
| Sizes | Length 80 to 130 cm; catheter gauge 6 to 8 Fr |
| Distribution end date | 2019-02-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MIA9090S | Length 90 cm | In distribution |
| MIA9080S | Length 80 cm | In distribution |
| MIA9095S | Length 95 cm | In distribution |
| MIA-57130 | Catheter Gauge 6 Fr | Withdrawn |
| MIA-57112 | Catheter Gauge 6 Fr | Withdrawn |
| MIA9090 | Catheter Gauge 8 Fr | Withdrawn |
| MIA9080 | Catheter Gauge 8 Fr | Withdrawn |
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 |
|---|---|
| K192558 | 2020-04-06 |
Recalls Naming This Product
2 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 |
|---|---|---|---|---|---|---|---|
| Mivi Neuroscience, Inc. | 510(k) number | 2021-07-23 | Class II | Packaging | There is potential for nonsterility of product due to a possible defect in the pouch seal. | 491 units | 2024-05-23 |
| Mivi Neuroscience, Inc. | 510(k) number | 2021-07-23 | Class II | Packaging | There is potential for nonsterility of product due to a possible defect in the pouch seal. | 68 units | 2024-05-23 |
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.