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FDA 510(k) Application Details - K130714
Device Classification Name
Catheter, Percutaneous
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510(K) Number
K130714
Device Name
Catheter, Percutaneous
Applicant
RADIUS MEDICAL, LLC
577 Main St Ste 360
Hudson, MA 01749 US
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Contact
RICHARD DEMELLO
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Regulation Number
870.1250
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Classification Product Code
DQY
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More FDA Info for this Product Code
Date Received
03/15/2013
Decision Date
08/22/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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