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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K001856
Device Name SUPERCROSS CATHETER
Applicant
Abbott Vascular, Inc.
400 Saginaw Dr.
Redwood,  CA  94063
Applicant Contact DAUN S PUTNAM
Correspondent
Abbott Vascular, Inc.
400 Saginaw Dr.
Redwood,  CA  94063
Correspondent Contact DAUN S PUTNAM
Regulation Number870.1250
Classification Product Code
DQY  
Date Received06/19/2000
Decision Date 03/07/2001
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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