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FDA 510(k) Application Details - K101062
Device Classification Name
Catheter, Angioplasty, Peripheral, Transluminal
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510(K) Number
K101062
Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Applicant
TRIREME MEDICAL INC
7060 KNOLL CENTER PARKWAY
SUITE 300
PLEASANTON, CA 94566 US
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Contact
SHIVA ARDAKANI
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
04/16/2010
Decision Date
05/12/2010
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
Y
Expedited Review
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