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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
- K242392PATH BGC2Cleared 510(K)
- K242289Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter2Cleared 510(K)
- K243593AXS Lift Intracranial Base Catheter2Cleared 510(K)
- K242051VersaD Delivery Catheter2Cleared 510(K)
- K243577Radical the Dude 8F Guide Catheter2Cleared 510(K)
- K243297APRO 70 Swift Catheter2Cleared 510(K)
- K241388Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter2Cleared 510(K)
- K242376Next Generation Access Platform2Cleared 510(K)
- K241768Broadway 8 Catheter2Cleared 510(K)
- K241637Echo Intracranial Base Catheter2Cleared 510(K)
Show All 74 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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Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K241388
- 510(k) Type
- Special
- Applicant
- Micro Therapeutics Inc. d/b/a ev3 Neurovascular
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/2/2025
- Days to Decision
- 232 days
- Submission Type
- Summary