FDA 510(k) Application Details - K033633

Device Classification Name Catheter, Percutaneous

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510(K) Number K033633
Device Name Catheter, Percutaneous
Applicant VASCON LLC
9344 NW 13 STREET
MIAMI, FL 33172 US
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Contact STEPHEN F VADAS
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Regulation Number 870.1250

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Classification Product Code DQY
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Date Received 11/19/2003
Decision Date 02/18/2004
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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