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FDA 510(k) Application Details - K142379
Device Classification Name
Catheter, Angioplasty, Peripheral, Transluminal
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510(K) Number
K142379
Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Applicant
BIOTRONIK, INC.
6024 JEAN ROAD
LAKE OSWEGO, OR 97035 US
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Contact
Jon Brumbaugh
Other 510(k) Applications for this Contact
Regulation Number
870.1250
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Classification Product Code
LIT
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More FDA Info for this Product Code
Date Received
08/26/2014
Decision Date
12/05/2014
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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