FDA 510(k) Application Details - K030260

Device Classification Name Dilator, Vessel, For Percutaneous Catheterization

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510(K) Number K030260
Device Name Dilator, Vessel, For Percutaneous Catheterization
Applicant VASCUMETRIX, LLC
1058 N. HIGLEY RD. #204
MESA, AZ 85205 US
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Contact NICK RAIBLE
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Regulation Number 870.1310

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Classification Product Code DRE
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Date Received 01/24/2003
Decision Date 02/20/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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