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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 K060947
Device Name SONICATH ULTRA IMAGING CATHETER, 3.2F,20MHZ MODELS 37410/456221/C1020
Applicant
Boston Scientific Corp
47900 Bayside Pkwy.
Fremont,  CA  94538
Applicant Contact ROBERT Z PHILLIPS
Correspondent
Boston Scientific Corp
47900 Bayside Pkwy.
Fremont,  CA  94538
Correspondent Contact ROBERT Z PHILLIPS
Regulation Number892.1570
Classification Product Code
ITX  
Date Received04/06/2006
Decision Date 04/19/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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