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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 K832698
Device Name ANGIOSCOPY CATHETER
Applicant
American Edwards Laboratories
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
American Edwards Laboratories
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.1500
Classification Product Code
LYK  
Date Received08/10/1983
Decision Date 11/03/1983
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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