Aristotle 18 Guidewire; Aristotle 24 Guidewire
FDA 510(k) K231954 · Scientia Vascular, Inc.
510(k) numberK231954
Submission
- Device name
- Aristotle 18 Guidewire; Aristotle 24 Guidewire
- Applicant
- Scientia Vascular, Inc.
West Valley City, UT, US - Received
- July 3, 2023
- Decision date
- August 1, 2023
- 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 |
| 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 |
| K210601 | Plato 17 MicrocatheterDQY · Traditional | 04/28/2021SE |
Questions and answers
When was Aristotle 18 Guidewire; Aristotle 24 Guidewire cleared by the FDA?
Aristotle 18 Guidewire; Aristotle 24 Guidewire (K231954) received a 510(k) decision of Substantially Equivalent on August 1, 2023, 29 days after the submission was received.
What is the product code of K231954?
The FDA product code is MOF – Guide, Wire, Catheter, Neurovasculature, a Class II (moderate risk) device regulated under 21 CFR 870.1330.