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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 K926433
Device Name 4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45
Applicant
Baxter Edwards
1402 Alton Ave.
Irvine,  CA  92714
Applicant Contact LAWRENCE STEVENS
Correspondent
Baxter Edwards
1402 Alton Ave.
Irvine,  CA  92714
Correspondent Contact LAWRENCE STEVENS
Regulation Number876.1500
Classification Product Code
LYK  
Date Received12/23/1992
Decision Date 03/23/1993
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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