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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Angiographic
510(k) Number K932410
Device Name HEARTVIEW(R) CORONARY ANGIOGRAPH DIAGRAM/REPORT SY
Applicant
Heartware Intl. Corp.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact CYNTHIA A SINCLAIR
Correspondent
Heartware Intl. Corp.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact CYNTHIA A SINCLAIR
Regulation Number892.1600
Classification Product Code
IZI  
Date Received05/18/1993
Decision Date 12/13/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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