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Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
MOF
Guide, Wire, Catheter, Neurovasculature
2
Product Code
NDQ
System, Catheter Or Guidewire, Steerable (Magnetic)
2
Product Code
K
06
0967
NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION
2
Cleared 510(K)
K
05
1373
CRONUS GUIDEWIRE, MODEL 001-001470-1
2
Cleared 510(K)
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
/
NDQ
/
K060967
View Source
NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K060967
510(k) Type
Traditional
Applicant
STEREOTAXIS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/19/2006
Days to Decision
195 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
NDQ
System, Catheter Or Guidewire, Steerable (Magnetic)
K
06
0967
NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION
K
05
1373
CRONUS GUIDEWIRE, MODEL 001-001470-1
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
/
NDQ
/
K060967
View Source
NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K060967
510(k) Type
Traditional
Applicant
STEREOTAXIS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/19/2006
Days to Decision
195 days
Submission Type
Summary