Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K042040
Device Classification Name
Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
More FDA Info for this Device
510(K) Number
K042040
Device Name
Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Applicant
KENSEY NASH CORP.
55 EAST UWCHLAN AVE.
MARSH CREEK CORP. CENTER
EXTON, PA 19341-1247 US
Other 510(k) Applications for this Company
Contact
ROBIN M FATZINGER
Other 510(k) Applications for this Contact
Regulation Number
870.1250
More FDA Info for this Regulation Number
Classification Product Code
NFA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/29/2004
Decision Date
03/23/2005
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact