Volo
Guidewire- Standard
5manufacturers in China registered for this device type
4catalogue numbers in this listing
8510(k) clearances naming this product code
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 | Scientia Vascular, United States |
|---|---|
| FDA product code | MOF |
| Device type | Guide, Wire, Catheter, Neurovasculature |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1330 |
| Establishment | Manufacturer |
| 510(k) | K181828 |
| Record published | 2020-02-24 |
| Record revised | 2024-04-01 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep dry, keep away from heat |
| Distribution end date | 2024-03-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14-300-002 | Withdrawn | |
| 14-300-001 | Withdrawn | |
| 14-200-001 | Withdrawn | |
| 14-200-002 | Withdrawn |
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 |
| Chikai black | Asahi Intecc Co., Ltd. | 4 |
| Chikai Nexus petit | Asahi Intecc Co., Ltd. | 3 |
| Agility | Cerenovus, Inc. | 3 |
| Traxcess | MicroVention, Inc. | 3 |
Showing 12 of 42. All products under Guide, Wire, Catheter, Neurovasculature
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260223 | 2026-08-06 |
| K253579 | 2026-04-29 |
| K243938 | 2025-04-01 |
| K231954 | 2023-08-01 |
| K220398 | 2023-03-10 |
| K222437 | 2023-01-26 |
| K183608 | 2019-03-22 |
| K181828 | 2018-08-07 |
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.