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510(k) Data Aggregation
K Number
K070680Device Name
CARDIOMEMS ENDOSURE S2 14F WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL# S2-2080
Manufacturer
Date Cleared
2007-04-05
(24 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 14F 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.
Device Description
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K Number
K061046Device Name
CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND INTERROGATOR, MODEL EMS 5001
Manufacturer
Date Cleared
2006-10-12
(181 days)
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. It may be used as an adjunctive tool in the detection of intraoperative endoleaks.
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 Interrogator
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