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510(k) Data Aggregation
K Number
K082191Device Name
CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080
Manufacturer
Date Cleared
2008-08-19
(15 days)
Product Code
Regulation Number
870.2855Why did this record match?
Applicant Name (Manufacturer) :
CARDIOMEMS INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CardioMEMS EndoSure s2 Wireless AAA Pressure Measurement System is intended for measuring intrasac pressure during endovascular abdominal aortic aneurysm (AAA) repair and may be used as an adjunctive tool in the detection of intraoperative endoleaks. It also may be used for measuring intrasac pressure during thoracic aortic aneurysm (TAA) repair.
Device Description
The CardioMEMS EndoSure s2 Wireless AAA Pressure Measurement System is designed to monitor pressure within the sac of a repaired aneurysm during endovascular stent graft placement. The CardioMEMS EndoSure s2 Wireless AAA Pressure Measurement System includes:
- The CardioMEMS EndoSure™ s2 Sensor with radio-opaque markings -(implant)
- A sterile Delivery System (pre-loaded with the CardioMEMS EndoSure™ s2 Sensor)
- CardioMEMS EndoSure™ Electronics System
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K Number
K070448Device Name
CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001
Manufacturer
Date Cleared
2007-03-15
(28 days)
Product Code
Regulation Number
870.2855Why did this record match?
Applicant Name (Manufacturer) :
CARDIOMEMS INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CardioMEMS EndoSure™ Wireless AAA Pressure Measurement System is intended for measuring intrasac pressure during endovascular abdominal aortic aneurysm (AAA) repair and may be used as an adjunctive tool in the detection of intraoperative endoleaks. It also may be used for measuring intrasac pressure during thoracic aortic aneurysm (TAA) repair.
Device Description
The CardioMEMS EndoSure™ Wireless AAA Pressure Measurement System is designed to monitor pressure within the sac of a repaired aneurysm during endovascular stent graft placement. The CardioMEMS EndoSure™ Wireless AAA Pressure Measurement System includes:
- The CardioMEMS EndoSure™ Sensor with radio-opaque markings (implant)
- A sterile Delivery System (pre-loaded with the CardioMEMS EndoSure™ Sensor)
- CardioMEMS EndoSure™ Electronics System
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K Number
DEN050006Device Name
CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM
Manufacturer
Date Cleared
2005-10-28
(80 days)
Product Code
Regulation Number
870.2855Why did this record match?
Applicant Name (Manufacturer) :
CARDIOMEMS INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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