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) K181828 · Scientia Vascular, LLC
510(k) numberK181828
Submission
- 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
West Valley City, UT, US - Received
- July 9, 2018
- Decision date
- August 7, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MOF – Guide, Wire, Catheter, Neurovasculature
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1330
- Specialty
- Cardiovascular
Other 510(k)s with product code MOF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260751 | 35 Helix GuidewireMOF · Traditional | Piraeus Medical, Inc. | 08/27/2026SE |
| K262424 | Willow 12 GuidewireMOF · Special | Arbor Endovascular, LLC | 08/14/2026SE |
| K260223 | Aristotle Mini GuidewireMOF · Traditional | Scientia Vascular, Inc. | 08/06/2026SE |
| K254006 | Drivewire 35 GuidewireMOF · Traditional | Rapid Medical Ltd. | 07/17/2026SE |
| K253579 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14…MOF · Traditional | Scientia Vascular, Inc. | 04/29/2026SE |
| K252317 | Zenith Micro GuidewireMOF · Traditional | Suzhou Zenith Vascular SciTech Limited | 04/16/2026SE |
| K260537 | Willow 24 GuidewireMOF · Special | Arbor Endovascular, LLC | 03/19/2026SE |
| K252122 | DCwire Micro-guidewireMOF · Traditional | Shanghai Achieva Medical Suzhou Co., Ltd. | 03/16/2026SE |
| K260130 | Willow 18 GuidewireMOF · Special | Arbor Endovascular, LLC | 02/13/2026SE |
| K252011 | CHIKAI Nexus petitMOF · Traditional | Asahi Intecc Co., Ltd. | 02/02/2026SE |
More from Asahi Intecc Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K260223 | Aristotle Mini GuidewireMOF · Traditional | 08/06/2026SE |
| K260002 | Socrates Aspiration System (Socrates 70 Aspiration Catheter)NRY · Traditional | 07/16/2026SE |
| K253579 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14…MOF · Traditional | 04/29/2026SE |
| K243938 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14…MOF · Special | 04/01/2025SE |
| K242301 | Socrates 38 CatheterQJP · Traditional | 12/04/2024SE |
| K223913 | Socrates Aspiration SystemNRY · Traditional | 09/20/2023SE |
| K223560 | Plato 17 MicrocatheterQJP · Traditional | 08/21/2023SE |
| K231954 | Aristotle 18 Guidewire; Aristotle 24 GuidewireMOF · Special | 08/01/2023SE |
| K220398 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14…MOF · Special | 03/10/2023SE |
| K222437 | Aristotle Colossus GuidewireMOF · Traditional | 01/26/2023SE |
Questions and answers
When was Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile cleared by the FDA?
Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile (K181828) received a 510(k) decision of Substantially Equivalent on August 7, 2018, 29 days after the submission was received.
What is the product code of K181828?
The FDA product code is MOF – Guide, Wire, Catheter, Neurovasculature, a Class II (moderate risk) device regulated under 21 CFR 870.1330.