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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 K973713
Device Name 22 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CAR
Applicant
Cardiovascular Dynamics, Inc.
13700 Alton Pkwy.
Irvine,  CA  92618
Applicant Contact PAMELA MISAJON
Correspondent
Cardiovascular Dynamics, Inc.
13700 Alton Pkwy.
Irvine,  CA  92618
Correspondent Contact PAMELA MISAJON
Regulation Number892.1570
Classification Product Code
ITX  
Date Received09/29/1997
Decision Date 01/23/1998
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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