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Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
MOF
Guide, Wire, Catheter, Neurovasculature
2
Product Code
K
24
0871
Synxess Neurovascular Guidewire
2
Cleared 510(K)
K
23
3791
Drivewire 24 Guidewire
2
Cleared 510(K)
K
23
1954
Aristotle 18 Guidewire; Aristotle 24 Guidewire
2
Cleared 510(K)
K
22
2690
SmartGUIDE deflectable hydrophilic guidewire
2
Cleared 510(K)
K
22
0398
Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire
2
Cleared 510(K)
K
22
2437
Aristotle Colossus Guidewire
2
Cleared 510(K)
K
22
0934
RADIFOCUS Torque Device
2
Cleared 510(K)
K
20
0374
Columbus Guidewire
2
Cleared 510(K)
K
20
2522
Synchro SELECT Guidewire
2
Cleared 510(K)
K
20
1487
Traxcess 7 Mini Guidewire
2
Cleared 510(K)
Show All 29 Submissions
NDQ
System, Catheter Or Guidewire, Steerable (Magnetic)
2
Product Code
NRY
Catheter, Thrombus Retriever
2
Product Code
NUI
Ultrasound, Infusion, System
2
Product Code
QBE
Cranial Sound Monitor
2
Product Code
QJP
Catheter, Percutaneous, Neurovasculature
2
Product Code
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Neurological Diagnostic Devices
CFR Sub-Part
Subpart B—Physical Medicine Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 6 December 2024 at 11:05 pm
NE
/
subpart-b—cardiovascular-diagnostic-devices
/
MOF
/
K201487
View Source
Traxcess 7 Mini Guidewire
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201487
510(k) Type
Special
Applicant
Micro Vention Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/2/2020
Days to Decision
28 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
MOF
Guide, Wire, Catheter, Neurovasculature
K
24
0871
Synxess Neurovascular Guidewire
K
23
3791
Drivewire 24 Guidewire
K
23
1954
Aristotle 18 Guidewire; Aristotle 24 Guidewire
K
22
2690
SmartGUIDE deflectable hydrophilic guidewire
K
22
0398
Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire
K
22
2437
Aristotle Colossus Guidewire
K
22
0934
RADIFOCUS Torque Device
K
20
0374
Columbus Guidewire
K
20
2522
Synchro SELECT Guidewire
K
20
1487
Traxcess 7 Mini Guidewire
Show All 29 Submissions
NDQ
System, Catheter Or Guidewire, Steerable (Magnetic)
NRY
Catheter, Thrombus Retriever
NUI
Ultrasound, Infusion, System
QBE
Cranial Sound Monitor
QJP
Catheter, Percutaneous, Neurovasculature
Subpart B—Diagnostic Devices
Subpart B—Neurological Diagnostic Devices
Subpart B—Physical Medicine Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
NE
/
subpart-b—cardiovascular-diagnostic-devices
/
MOF
/
K201487
View Source
Traxcess 7 Mini Guidewire
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201487
510(k) Type
Special
Applicant
Micro Vention Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/2/2020
Days to Decision
28 days
Submission Type
Summary