510(k) K181828
- Device
- 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
- 510(k) number
- K181828
- Product code
- MOF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-08-07
- Date received
- 2018-07-09
- Regulation
- 870.1330
- Classification name
- Guide, Wire, Catheter, Neurovasculature
- Medical specialty
- Cardiovascular
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- David Sabodski
- Address
- 3487 W. 2100 S., Suite 100 West Valley City UT US 84119 84119
FDA Registration Numbers#
- 3009121749
- 1721676
- 3026317086
- 3039642752
- 3013556777
- 3012931345
- 2011171
- 3003780911
- 3008837339
- 3034543750
- 3008114965
- 3008853977
- 3014162263
- 2029214
- 3007628272
- 1220477
- 3016119728
- 3014590708
- 3009957947
- 3004102031
- 3003775027
- 3010163695
- 8023054
- 1226348
- 3015550451
- 3009546466
- 3013656790
- 3030452144
- 3015531723
- 3017210488
Source Documents#
Other 510(k) Records For Product Code MOF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253579 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire | Scientia Vascular, Inc. | 2026-04-29 |
| K252317 | Zenith Micro Guidewire | Suzhou Zenith Vascular SciTech Limited | 2026-04-16 |
| K260537 | Willow 24 Guidewire | Arbor Endovascular, LLC | 2026-03-19 |
| K252122 | DCwire Micro-guidewire | Shanghai Achieva Medical Suzhou Co., Ltd. | 2026-03-16 |
| K260130 | Willow 18 Guidewire | Arbor Endovascular, LLC | 2026-02-13 |
| K252011 | CHIKAI Nexus petit | Asahi Intecc Co., Ltd. | 2026-02-02 |
| K253168 | 0.014” Willow Guidewire | Arbor Endovascular, LLC | 2025-11-26 |
| K244061 | X-Wire Guidewire | Imperative Care, Inc. | 2025-08-26 |
| K243756 | 0.014” Willow Guidewire | Arbor Endovascular, LLC | 2025-07-17 |
| K243383 | CHIKAI Nexus 014 | Asahi Intecc Co., Ltd. | 2025-04-21 |
| K243938 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire | Scientia Vascular, Inc. | 2025-04-01 |
| K240871 | Synxess Neurovascular Guidewire | Enlight Medical Technologies (Shenzhen) Co., Ltd. | 2024-11-18 |
| K233791 | Drivewire 24 Guidewire | Rapid-Medical , Ltd. | 2024-07-11 |
| K231954 | Aristotle 18 Guidewire; Aristotle 24 Guidewire | Scientia Vascular, Inc. | 2023-08-01 |
| K222690 | SmartGUIDE deflectable hydrophilic guidewire | Artiria Medical SA | 2023-04-24 |
Legacy Summary#
summary
FDA Review#
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