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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K834429
Device Name PERIPHERAL DILATATION ANGIOPLASTY-CATH
Applicant
American Edwards Laboratories
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
American Edwards Laboratories
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.1250
Classification Product Code
LIT  
Date Received12/15/1983
Decision Date 08/10/1984
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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