FDA 510(k) Application Details - K072155

Device Classification Name

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510(K) Number K072155
Device Name PIONEER CATHETER
Applicant MEDTRONIC INC.
3576 UNOCAL PLACE
SANTA ROSA, CA 95403-1774 US
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Contact CATHERINE PRIESTLEY
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Regulation Number

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Classification Product Code PDU
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Date Received 08/03/2007
Decision Date 10/05/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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