The Drivewire Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The Drivewire Guidewire is intended to facilitate the selective placement…
The Drivewire Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The Drivewire Guidewire is intended to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries.
Who Else Makes It
Concentrated in Jiangsu (2), Zhejiang (1), Beijing (1).
Record
Regulatory record for Drivewire LR | Listed by | Rapid-Medical Ltd, Israel |
| FDA product code | MOF |
| Device type | Guide, Wire, Catheter, Neurovasculature |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1330 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K200374 |
| Record published | 2021-08-26 |
Specifications
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 |
| Packaging | Pack of 5 |
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.