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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intracardiac mapping, high-density array
510(k) Number K000277
Device Name CONSTELLATION CATHETERS
Applicant
BOSTON SCIENTIFIC CORP.
2710 ORCHARD PKWY.
SAN JOSE,  CA  95134
Applicant Contact ANDREA BOUMIS
Correspondent
BOSTON SCIENTIFIC CORP.
2710 ORCHARD PKWY.
SAN JOSE,  CA  95134
Correspondent Contact ANDREA BOUMIS
Regulation Number870.1220
Classification Product Code
MTD  
Date Received01/31/2000
Decision Date 09/26/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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