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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 K963989
Device Name P.D. ACCESS (PERCUTANEOUS DOPPLER) VASCULAR ACCESS DEVICE
Applicant
Cardiovascular Dynamics, Inc.
13900 Alton Pkwy., Suite 122
Irvine,  CA  92618
Applicant Contact MICHAEL CROCKER
Correspondent
Cardiovascular Dynamics, Inc.
13900 Alton Pkwy., Suite 122
Irvine,  CA  92618
Correspondent Contact MICHAEL CROCKER
Regulation Number892.1570
Classification Product Code
ITX  
Date Received10/04/1996
Decision Date 04/24/1997
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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