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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 K010853
Device Name GUIDER SOFTIP GUIDING CATHETER XF 5F
Applicant
BOSTON SCIENTIFIC, TARGET
47900 BAYSIDE PKWY.
FREMONT,  CA  94538
Applicant Contact ROXANE K BAXTER
Correspondent
BOSTON SCIENTIFIC, TARGET
47900 BAYSIDE PKWY.
FREMONT,  CA  94538
Correspondent Contact ROXANE K BAXTER
Regulation Number870.1250
Classification Product Code
DQY  
Date Received03/21/2001
Decision Date 04/18/2001
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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