Drivewire 35 Guidewire
The Drivewire 35 Guidewire assists selective placement of diagnostic or therapeutic catheters in the neurovascular and peripheral circulation. It is a 0.035-inch steerable guidewire with a…
The Drivewire 35 Guidewire assists selective placement of diagnostic or therapeutic catheters in the neurovascular and peripheral circulation. It is a 0.035-inch steerable guidewire with a deflectable tip and is not intended for coronary artery use.
The proximal handle moves an inner core wire backwards or forwards to bend the distal tip in two directions. A flexible cut stainless-steel hypotube and an inner nitinol braided coil form part of the guidewire structure. Handle markings identify the straight-tip position.
Listed Item
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 the coronary arteries.
Navigation and Supply
A hydrophilic coating on the distal segment reduces friction during navigation. The guidewire is supplied sterile for single use, with a separate torquer accessory to assist handling.
Who Else Makes It
Concentrated in Jiangsu (2), Zhejiang (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Terumo Medical Products (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Shanghai Achieva Medical Suzhou Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
| Deepintec Scientific Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| Enlight Medical Technologies (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 1 |
Record
| 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) | K254006 |
| Record published | 2026-07-20 |
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: Store in a dry place at room temperature in its designated box |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DRPP3511 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Willow 14 Guidewire | Arbor Endovascular | 22 |
| Cypress 14 Guidewire | Arbor Endovascular | 9 |
| Aristotle | Scientia Vascular | 8 |
| DCwire™ | Shanghai Achieva Medical Suzhou Co., Ltd. | 8 |
| Synchro Select | Stryker GmbH | 6 |
| Chikai Nexus 014 | Asahi Intecc Co., Ltd. | 6 |
| Hybrid Guidewire | Balt USA, LLC | 5 |
| Chikai | Asahi Intecc Co., Ltd. | 4 |
| Volo | Scientia Vascular | 4 |
| Chikai black | Asahi Intecc Co., Ltd. | 4 |
| Chikai Nexus petit | Asahi Intecc Co., Ltd. | 3 |
| Agility | Cerenovus, Inc. | 3 |
Showing 12 of 42. All products under Guide, Wire, Catheter, Neurovasculature
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K254006 | 2026-07-17 |
| K233791 | 2024-07-11 |
| K200374 | 2020-12-14 |
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.