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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K982329
Device Name VISIONS 8.2F PV ULTRASONIC IMAGING CATHETER (MODEL 88900)
Applicant
Endosonics Corp.
2870 Kilgore Rd..
Rancho Cordova,,  CA  95670
Applicant Contact ADAM D SAVAKUS
Correspondent
Endosonics Corp.
2870 Kilgore Rd..
Rancho Cordova,,  CA  95670
Correspondent Contact ADAM D SAVAKUS
Regulation Number892.1570
Classification Product Code
ITX  
Date Received07/02/1998
Decision Date 01/14/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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