Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- MOFGuide, Wire, Catheter, Neurovasculature2Product Code
- K244061X-Wire Guidewire2Cleared 510(K)
- K2437560.014” Willow Guidewire2Cleared 510(K)
- K243383CHIKAI Nexus 0142Cleared 510(K)
- K243938Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire2Cleared 510(K)
- 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)
- K200547Traxcess 14 SELECT Guidewire2Cleared 510(K)
- K191714ASAHI Neurovascular Guide Wire CHIKAI X 014 soft2Cleared 510(K)
- K190843Synchro2 Support Guidewire2Cleared 510(K)
- K183608Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile2Cleared 510(K)
- K183070ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 0102Cleared 510(K)
- K182337HYBRID Guidewire2Cleared 510(K)
- K181828Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile2Cleared 510(K)
- K171613ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip2Cleared 510(K)
- K163154Traxcess 7 Mini XSoft Guidewire2Cleared 510(K)
- K161912ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip2Cleared 510(K)
- K161803Traxcess .007 Mini Guidewire2Cleared 510(K)
- K160659ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)2Cleared 510(K)
- K153053Traxcess Pro 14 Guidewire2Cleared 510(K)
- K151825Viradius Neurowire2Cleared 510(K)
- K141751ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK, ASAHI NEUROVASCULAR2Cleared 510(K)
- K133725TRAXCESS 14 GUIDEWIRE2Cleared 510(K)
- K133625AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD &2Cleared 510(K)
- K112979ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE2Cleared 510(K)
- K110584ASAHI CHIKAI NEUROVASCULAR GUIDE WIRE2Cleared 510(K)
- 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
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
RADIFOCUS Torque Device
- Page Type
- Cleared 510(K)
- 510(k) Number
- K220934
- 510(k) Type
- Traditional
- Applicant
- Terumo Medical Products (Hangzhou) Co., Ltd.
- Country
- China
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/29/2022
- Days to Decision
- 90 days
- Submission Type
- Summary