FDA 510(k) Application Details - K963663

Device Classification Name Catheter, Percutaneous

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510(K) Number K963663
Device Name Catheter, Percutaneous
Applicant BOSTON SCIENTIFIC /INTERNATIONAL TECHNOLOGIES
3574 RUFFIN RD.
SAN DIEGO, CA 92123 US
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Contact MICHAEL E KLICPERA
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Regulation Number 870.1250

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Classification Product Code DQY
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Date Received 09/13/1996
Decision Date 01/13/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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