Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile
FDA 510(k) clearance K181828 · decided 2018-08-07
Clearance details
- K-number
- K181828
- Device name
- Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile
- Applicant
- Scientia Vascular, LLC
- Decision
- Substantially Equivalent
- Date received
- 2018-07-09
- Decision date
- 2018-08-07
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- MOF
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- West Valley City, UT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Aristotle Mini Guidewire (K260223) | Scientia Vascular, Inc. | 2026-08-06 |
| Drivewire 35 Guidewire (K254006) | Rapid Medical Ltd. | 2026-07-17 |
| Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire (K253579) | Scientia Vascular, Inc. | 2026-04-29 |
| Zenith Micro Guidewire (K252317) | Suzhou Zenith Vascular SciTech Limited | 2026-04-16 |
| Willow 24 Guidewire (K260537) | Arbor Endovascular, LLC | 2026-03-19 |
| DCwire Micro-guidewire (K252122) | Shanghai Achieva Medical Suzhou Co., Ltd. | 2026-03-16 |
| Willow 18 Guidewire (K260130) | Arbor Endovascular, LLC | 2026-02-13 |
| CHIKAI Nexus petit (K252011) | Asahi Intecc Co., Ltd. | 2026-02-02 |
| 0.014” Willow Guidewire (K253168) | Arbor Endovascular, LLC | 2025-11-26 |
| X-Wire Guidewire (K244061) | Imperative Care, Inc. | 2025-08-26 |
| 0.014” Willow Guidewire (K243756) | Arbor Endovascular, LLC | 2025-07-17 |
| CHIKAI Nexus 014 (K243383) | Asahi Intecc Co., Ltd. | 2025-04-21 |
Recalls involving this device
No recalls on record reference this clearance.