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FDA 510(k) Application Details - K060666
Device Classification Name
Introducer, Catheter
More FDA Info for this Device
510(K) Number
K060666
Device Name
Introducer, Catheter
Applicant
TERUMO MEDICAL CORP.
125 BLUE BALL RD.
ELKTON, MD 21921 US
Other 510(k) Applications for this Company
Contact
MARK UNTERREINER
Other 510(k) Applications for this Contact
Regulation Number
870.1340
More FDA Info for this Regulation Number
Classification Product Code
DYB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/14/2006
Decision Date
06/29/2006
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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