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Innolitics
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Review Panel
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Review Panel
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Review Panel
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Review Panel
General Hospital
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Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
DQF
Actuator, Syringe, Injector Type
2
Product Code
DQI
Withdrawal/Infusion Pump
2
Product Code
K
96
0486
KSEA MODEL 383320 20 ANGIOMAT
2
Cleared 510(K)
K
93
5763
SURGIPUMP
2
Cleared 510(K)
K
92
2541
USCI SUPER 9 PTCA GUIDING CATHETER
2
Cleared 510(K)
K
92
4110
LEOCOR CORFLO PUMP -- MODIFICATION
2
Cleared 510(K)
K
90
5189
BAXTER ANGIOSCOPY PUMP TUBING SET (MODEL NL)
2
Cleared 510(K)
K
90
2444
CLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMP
2
Cleared 510(K)
K
89
5688
NOBLES-LAI ENGINEERING INFUSION PUMP
2
Cleared 510(K)
K
89
5074
ANGIOSCOPY PUMP
2
Cleared 510(K)
K
87
1422
OLYMPUS ANGIOSCOPY PUMP
2
Cleared 510(K)
DXT
Injector And Syringe, Angiographic
2
Product Code
IZQ
Injector, Contrast Medium, Automatic
2
Product Code
NKP
Injector, Contrast Medium, Automatic, Reprocessed
2
Product Code
NKT
Injector And Syringe, Angiographic, Reprocessed
2
Product Code
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
Subpart D—Pathology Instrumentation and Accessories
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use 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
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
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
HO
/
subpart-b—cardiovascular-diagnostic-devices
/
DQI
/
K871422
View Source
OLYMPUS ANGIOSCOPY PUMP
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K871422
510(k) Type
Traditional
Applicant
OLYMPUS CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/12/1987
Days to Decision
125 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
DQF
Actuator, Syringe, Injector Type
DQI
Withdrawal/Infusion Pump
K
96
0486
KSEA MODEL 383320 20 ANGIOMAT
K
93
5763
SURGIPUMP
K
92
2541
USCI SUPER 9 PTCA GUIDING CATHETER
K
92
4110
LEOCOR CORFLO PUMP -- MODIFICATION
K
90
5189
BAXTER ANGIOSCOPY PUMP TUBING SET (MODEL NL)
K
90
2444
CLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMP
K
89
5688
NOBLES-LAI ENGINEERING INFUSION PUMP
K
89
5074
ANGIOSCOPY PUMP
K
87
1422
OLYMPUS ANGIOSCOPY PUMP
DXT
Injector And Syringe, Angiographic
IZQ
Injector, Contrast Medium, Automatic
NKP
Injector, Contrast Medium, Automatic, Reprocessed
NKT
Injector And Syringe, Angiographic, Reprocessed
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—General Hospital and Personal Use Monitoring Devices
Subpart D—Pathology Instrumentation and Accessories
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
Subpart G—Miscellaneous Devices
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
HO
/
subpart-b—cardiovascular-diagnostic-devices
/
DQI
/
K871422
View Source
OLYMPUS ANGIOSCOPY PUMP
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K871422
510(k) Type
Traditional
Applicant
OLYMPUS CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/12/1987
Days to Decision
125 days