FUBUKI XF-R Neurovascular Long Sheath
FDA 510(k) K251560 · Asahi Intecc Co., Ltd.
510(k) numberK251560
Submission
- Device name
- FUBUKI XF-R Neurovascular Long Sheath
- Applicant
- Asahi Intecc Co., Ltd.
Seto, JP - Received
- May 21, 2025
- Decision date
- June 20, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QJP – Catheter, Percutaneous, Neurovasculature
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
To provide vascular access to the neurovasculature for interventional or diagnostic procedures
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|---|---|---|---|
| K262277 | 70 NeuGlide CatheterQJP · Special | Piraeus Medical, Inc. | 09/04/2026SE |
| K261176 | Zoom 4S CatheterQJP · Traditional | Imperative Care, Inc. | 08/28/2026SE |
| K254071 | p17 XR MicrocatheterQJP · Traditional | Wallaby Medical | 08/18/2026SE |
| K260199 | SLIM MicrocatheterQJP · Traditional | Balt USA, LLC | 07/13/2026SE |
| K253901 | Millipede88 Access CatheterQJP · Traditional | Perfuze, Ltd. | 07/09/2026SE |
| K261889 | Trevo Trak 21 MicrocatheterQJP · Special | Stryker Neurovascular | 07/01/2026SE |
| K261808 | ISAAC Neurovascular Navigation CatheterQJP · Special | Microvention Inc. d/b/a Terumo Neuro | 06/30/2026SE |
| K261549 | BOBBY Balloon Guide CatheterQJP · Special | MicroVention, Inc., d/b/a Terumo Neuro | 06/09/2026SE |
| K253359 | Zenith Distal Access Long SheathQJP · Traditional | Suzhou Zenith Vascular SciTech Limited | 05/22/2026SE |
| K254178 | SAYA 86 Radial Access Guide CatheterQJP · Traditional | Asahi Intecc Co., Ltd. | 05/11/2026SE |
More from Asahi Intecc Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K254178 | SAYA 86 Radial Access Guide CatheterQJP · Traditional | 05/11/2026SE |
| K252011 | CHIKAI Nexus petitMOF · Traditional | 02/02/2026SE |
| K251240 | Branchor X Balloon Guide CatheterQJP · Traditional | 06/20/2025SE |
| K243383 | CHIKAI Nexus 014MOF · Traditional | 04/21/2025SE |
| K243733 | SION blue PLUSDQX · Special | 04/02/2025SE |
| K241962 | CrossloopDQX · Traditional | 03/27/2025SE |
| K242597 | CROSSLEAD 0.018inchDQX · Special | 03/05/2025SE |
| K241702 | CROSSLEAD 0.014inchDQX · Special | 02/06/2025SE |
| K241801 | Tornus ESFGE · Traditional | 12/17/2024SE |
| K241510 | CROSSLEAD TrackerDQX · Special | 08/14/2024SE |
Questions and answers
When was FUBUKI XF-R Neurovascular Long Sheath cleared by the FDA?
FUBUKI XF-R Neurovascular Long Sheath (K251560) received a 510(k) decision of Substantially Equivalent on June 20, 2025, 30 days after the submission was received.
What is the product code of K251560?
The FDA product code is QJP – Catheter, Percutaneous, Neurovasculature, a Class II (moderate risk) device regulated under 21 CFR 870.1250.