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Found 3 results
510(k) Data Aggregation
K Number
K153488Device Name
Occlusion Perfusion Catheter
Manufacturer
Advanced Catheter Therapies, Inc.
Date Cleared
2016-02-25
(83 days)
Product Code
QEY, DQY
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
Advanced Catheter Therapies, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Occlusion Perfusion Catheter™ is indicated for localized infusion of various diagnostic and therapeutic agents into the peripheral vasculature. The Occlusion Perfusion Catheter™ may be repositioned for multiple treatments with the same patient. It is not indicated for use in the neurovasculature.
Device Description
Not Found
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K Number
K151554Device Name
Occlusion Perfusion Catheter
Manufacturer
ADVANCED CATHETER THERAPIES, INC.
Date Cleared
2015-09-15
(98 days)
Product Code
QEY, DOY
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED CATHETER THERAPIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Occlusion Perfusion Catheter™ is indicated for localized infusion of various diagnostic and therapeutic agents into the peripheral vasculature. It is not indicated for use in the neurovasculature.
Device Description
Not Found
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K Number
K130525Device Name
OCCLUSION PERFUSION CATHETER
Manufacturer
ADVANCED CATHETER THERAPIES, INC.
Date Cleared
2013-10-03
(217 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED CATHETER THERAPIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Occlusion Perfusion Catheter 10 is indicated for localized infusion or irrigation of various diagnostic and therapeutic agents into the peripheral vasculature. It is not indicated for use in the neurovasculature.
Device Description
Not Found
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