FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
LYK
Angioscope
2
Product Code
PZO
Software For Visualization Of Vascular Anatomy And Intravascular Devices
2
Product Code
K
24
2124
Sim&Size
2
Cleared 510(K)
K
23
0006
Ankyras
2
Cleared 510(K)
K
22
2664
Sim&Size
2
Cleared 510(K)
K
21
3838
AneuGuide
2
Cleared 510(K)
K
21
2373
Sim&Size
2
Cleared 510(K)
K
20
2322
Sim&Size
2
Cleared 510(K)
K
19
0049
Sim&Size
2
Cleared 510(K)
K
17
1534
SurgicalPreview
2
Cleared 510(K)
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart D—Cardiovascular Prosthetic Devices
CFR Sub-Part
Subpart E—Cardiovascular Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
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 16 May 2025 at 11:05 pm
CV
/
subpart-b—diagnostic-devices
/
PZO
/
K171534
View Source
SurgicalPreview
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K171534
510(k) Type
Traditional
Applicant
Endo Vantage, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/8/2017
Days to Decision
167 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
LYK
Angioscope
PZO
Software For Visualization Of Vascular Anatomy And Intravascular Devices
K
24
2124
Sim&Size
K
23
0006
Ankyras
K
22
2664
Sim&Size
K
21
3838
AneuGuide
K
21
2373
Sim&Size
K
20
2322
Sim&Size
K
19
0049
Sim&Size
K
17
1534
SurgicalPreview
Subpart C—Cardiovascular Monitoring Devices
Subpart D—Cardiovascular Prosthetic Devices
Subpart E—Cardiovascular Surgical Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Therapeutic Devices
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
CV
/
subpart-b—diagnostic-devices
/
PZO
/
K171534
View Source
SurgicalPreview
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K171534
510(k) Type
Traditional
Applicant
Endo Vantage, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/8/2017
Days to Decision
167 days
Submission Type
Summary