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FDA 510(k) Application Details - K060092
Device Classification Name
More FDA Info for this Device
510(K) Number
K060092
Device Name
QUICKCAT EXTRACTION CATHETER
Applicant
KENSEY NASH CORP.
735 PENNSYLVANIA AVE.
EXTON, PA 19341 US
Other 510(k) Applications for this Company
Contact
DEBORAH L JACKSON
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QEZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/12/2006
Decision Date
03/09/2006
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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