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- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- MOFGuide, Wire, Catheter, Neurovasculature2Product Code
- K240871Synxess Neurovascular Guidewire2Cleared 510(K)
- K233791Drivewire 24 Guidewire2Cleared 510(K)
- K231954Aristotle 18 Guidewire; Aristotle 24 Guidewire2Cleared 510(K)
- K222690SmartGUIDE deflectable hydrophilic guidewire2Cleared 510(K)
- K220398Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire2Cleared 510(K)
- K222437Aristotle Colossus Guidewire2Cleared 510(K)
- K220934RADIFOCUS Torque Device2Cleared 510(K)
- K200374Columbus Guidewire2Cleared 510(K)
- K202522Synchro SELECT Guidewire2Cleared 510(K)
- K201487Traxcess 7 Mini Guidewire2Cleared 510(K)
Show All 29 Submissions
- NDQSystem, Catheter Or Guidewire, Steerable (Magnetic)2Product Code
- NRYCatheter, Thrombus Retriever2Product Code
- 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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Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K220398
- 510(k) Type
- Special
- Applicant
- Scientia Vascular, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/10/2023
- Days to Decision
- 392 days
- Submission Type
- Summary