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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Angioscope
510(k) Number K952638
Device Name 4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[
Applicant
Baxter Edwards
17221 Red Hill Ave.
P.O. Box 11150
Santa Ana,  CA  92711
Applicant Contact RIC RUEDY
Correspondent
Baxter Edwards
17221 Red Hill Ave.
P.O. Box 11150
Santa Ana,  CA  92711
Correspondent Contact RIC RUEDY
Regulation Number876.1500
Classification Product Code
LYK  
Date Received06/09/1995
Decision Date 07/28/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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