Drivewire 24 Guidewire
FDA 510(k) K233791 · Rapid-Medical , Ltd.
510(k) numberK233791
Submission
- Device name
- Drivewire 24 Guidewire
- Applicant
- Rapid-Medical , Ltd.
Yokneam, IL - Received
- November 28, 2023
- Decision date
- July 11, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K260617 | Tigertriever 13 Ultra Revascularization DeviceNRY · Traditional | 08/28/2026SE |
| K254006 | Drivewire 35 GuidewireMOF · Traditional | 07/17/2026SE |
| K253062 | Tigertriever 25 Revascularization DeviceNRY · Traditional | 03/12/2026SE |
| K251603 | Tigertriever 17 Ultra Revascularization DeviceNRY · Traditional | 10/06/2025SE |
| K230429 | Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device…NRY · Special | 04/17/2023SE |
| K220808 | Tigertriever 13 Revascularization DeviceNRY · Traditional | 07/25/2022SE |
| K203592 | Tigertriever and Tigertriever 17 Revascularization DevceNRY · Traditional | 03/23/2021SE |
| K200374 | Columbus GuidewireMOF · Traditional | 12/14/2020SE |
Questions and answers
When was Drivewire 24 Guidewire cleared by the FDA?
Drivewire 24 Guidewire (K233791) received a 510(k) decision of Substantially Equivalent on July 11, 2024, 226 days after the submission was received.
What is the product code of K233791?
The FDA product code is MOF – Guide, Wire, Catheter, Neurovasculature, a Class II (moderate risk) device regulated under 21 CFR 870.1330.