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- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- MOFGuide, Wire, Catheter, Neurovasculature2Product Code
- NDQSystem, Catheter Or Guidewire, Steerable (Magnetic)2Product Code
- NRYCatheter, Thrombus Retriever2Product Code
- NUIUltrasound, Infusion, System2Product Code
- QBECranial Sound Monitor2Product Code
- QJPCatheter, Percutaneous, Neurovasculature2Product Code
- K252297Toro 88 Superbore Catheter2Cleared 510(K)
- K251097V-DAC Catheter2Cleared 510(K)
- K251668SurfRider 13 Microcatheter2Cleared 510(K)
- K252213Bendit17 Microcatheter2Cleared 510(K)
- K251372VersaD Delivery Catheter2Cleared 510(K)
- K252569Carrier XL Delivery Catheter2Cleared 510(K)
- K250960DUO Microcatheter2Cleared 510(K)
- K251560FUBUKI XF-R Neurovascular Long Sheath2Cleared 510(K)
- K251240Branchor X Balloon Guide Catheter2Cleared 510(K)
- K25104493 NeuFlex Catheter2Cleared 510(K)
Show All 84 Submissions
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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FUBUKI XF-R Neurovascular Long Sheath
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K251560
- 510(k) Type
- Special
- Applicant
- Asahi Intecc Co., Ltd.
- Country
- Japan
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/20/2025
- Days to Decision
- 30 days
- Submission Type
- Summary