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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
- K251789EMBOTRAP III Revascularization Device2Cleared 510(K)
- K252392Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set2Cleared 510(K)
- K251828CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set2Cleared 510(K)
- K243948Raptor Aspiration Catheter; Balt Aspiration Tubing Set2Cleared 510(K)
- K243047Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing2Cleared 510(K)
- K243601Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set2Cleared 510(K)
- K251015APRO 45 Catheter and Alembic Aspiration Tubing2Cleared 510(K)
- K250958APRO 55 Swift Catheter and Alembic Aspiration Tubing2Cleared 510(K)
- K250012Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set2Cleared 510(K)
- K243287APRO 70 Swift Catheter and Alembic Aspiration Tubing2Cleared 510(K)
Show All 100 Submissions
- NUIUltrasound, Infusion, System2Product Code
- QBECranial Sound Monitor2Product Code
- QJPCatheter, Percutaneous, Neurovasculature2Product Code
- 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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Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K243601
- 510(k) Type
- Traditional
- Applicant
- Route 92 Medical, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/19/2025
- Days to Decision
- 179 days
- Submission Type
- Summary