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FDA 510(k) Application Details - K133843
Device Classification Name
Catheter, Angioplasty, Peripheral, Transluminal
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510(K) Number
K133843
Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Applicant
CORDIS CORPORATION
6500 PASEO PADRE PKWY
FREMONT, CA 94555 US
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Contact
KIM FONDA
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Regulation Number
870.1250
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Classification Product Code
LIT
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Date Received
12/18/2013
Decision Date
06/27/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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