Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K113869
Device Classification Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
More FDA Info for this Device
510(K) Number
K113869
Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant
Origen Biomedical, Inc.
7000 BURLESON ROAD
BLDG D
AUSTIN, TX 78744 US
Other 510(k) Applications for this Company
Contact
RICHARD MARTIN
Other 510(k) Applications for this Contact
Regulation Number
870.4210
More FDA Info for this Regulation Number
Classification Product Code
DWF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/30/2011
Decision Date
07/26/2012
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