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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 K021232
Device Name CONSTELLATION CATHETERS, MODEL 8031M
Applicant
Boston Scientific Corp
2710 Orchard Pkwy.
San Jose,  CA  95134
Applicant Contact CHRISTINA L ROWE
Correspondent
Boston Scientific Corp
2710 Orchard Pkwy.
San Jose,  CA  95134
Correspondent Contact CHRISTINA L ROWE
Regulation Number870.1220
Classification Product Code
MTD  
Date Received04/18/2002
Decision Date 05/16/2002
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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