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FDA 510(k) Application Details - K092361
Device Classification Name
Catheter, Angioplasty, Peripheral, Transluminal
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510(K) Number
K092361
Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Applicant
INVATEC S.P.A.
3101 EMRICK BLVD
BETHLEHEM, PA 18020 US
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Contact
JOHN CLAY
Other 510(k) Applications for this Contact
Regulation Number
870.1250
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Classification Product Code
LIT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/04/2009
Decision Date
10/29/2009
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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