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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 K041727
Device Name MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456
Applicant
Boston Scientific Scimed, Inc.
47900 Bayside Pkwy.
Fremont,  CA  94538
Applicant Contact ROBERT Z PHILLIPS
Correspondent
Boston Scientific Scimed, Inc.
47900 Bayside Pkwy.
Fremont,  CA  94538
Correspondent Contact ROBERT Z PHILLIPS
Regulation Number870.1200
Classification Product Code
OBJ  
Date Received06/25/2004
Decision Date 07/23/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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