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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K933517
Device Name AUTOMATIC PULL BACK DEVICE
Applicant
Cardiovascular Imaging Systems, Inc.
595 N. Pastoria Ave.
Sunnyvale,  CA  94085
Applicant Contact YUE-TEH JANG
Correspondent
Cardiovascular Imaging Systems, Inc.
595 N. Pastoria Ave.
Sunnyvale,  CA  94085
Correspondent Contact YUE-TEH JANG
Regulation Number870.1330
Classification Product Code
DQX  
Date Received07/20/1993
Decision Date 10/15/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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