FDA 510(k) Application Details - K123591

Device Classification Name Catheter, Steerable

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510(K) Number K123591
Device Name Catheter, Steerable
Applicant MEDTRONIC CRYOCATH LP
8200 CORAL SEA STREET NE
MS MVS46
MOUNDS VIEW, MN 55112 US
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Contact VANESSA WARE
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Regulation Number 870.1280

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Classification Product Code DRA
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Date Received 11/21/2012
Decision Date 12/27/2012
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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