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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Ultrasound, Intravascular
510(k) Number K051337
Device Name EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900/859XX; VOLCANO VH-IVUS SYSTEM, MODEL 8049XX-001
Applicant
Volcano Corporation
2870 Kilgore Rd..
Rancho Cordova,,  CA  95670
Applicant Contact LORRY HUFFMAN
Correspondent
Volcano Corporation
2870 Kilgore Rd..
Rancho Cordova,,  CA  95670
Correspondent Contact LORRY HUFFMAN
Regulation Number870.1200
Classification Product Code
OBJ  
Subsequent Product Code
IYO  
Date Received05/23/2005
Decision Date 08/18/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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