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510(k) Data Aggregation
K Number
K030532Device Name
CPCA2000 COUNTERPULSATION SYSTEM
Manufacturer
Date Cleared
2003-03-14
(23 days)
Product Code
Regulation Number
870.5225Why did this record match?
Applicant Name (Manufacturer) :
CPCA2000 INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CPCA2000™ Counterpulsation System is a non-invasive external counterpulsation device intended for use in the treatment of patients with stable or unstable angina pectoris, congestive heart failure, acute myocardial infarction and cardiogenic shock. Use of this device may reduce pain and impairment associated with angina pectoris, congestive heart failure or myocardial infarction and may enhance coronary function.
Device Description
The CPCA2000 Counter Pulsation System consists of a portable console containing computer, electrocardiogram. plethysmogram, pump and reservoir, integral strip chart recorder, and leg cuffs and hoses. The microprocessor is used to operate and monitor the system via proprietary software, with the operator using touch screen interface to control its operation. The screen displays information pertinent to operating the system, as well as treatment parameters and patient waveforms during use. An external floppy disk drive is used to record data onto transferable media, and a printer is used to produce a hard copy of site, patient and physiologic data. The system accommodates the use of any bed or treatment table.
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