Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K061031
Device Classification Name
Oxygenator, Cardiopulmonary Bypass
More FDA Info for this Device
510(K) Number
K061031
Device Name
Oxygenator, Cardiopulmonary Bypass
Applicant
SORIN GROUP ITALIA S.R.L.
200 WEST STREET
WALTHAM, MA 02451 US
Other 510(k) Applications for this Company
Contact
BARRY SALL
Other 510(k) Applications for this Contact
Regulation Number
870.4350
More FDA Info for this Regulation Number
Classification Product Code
DTZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/14/2006
Decision Date
06/02/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact