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FDA 510(k) Application Details - K123591
Device Classification Name
Catheter, Steerable
More FDA Info for this Device
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
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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