Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K102726
Device Classification Name
Console, Heart-Lung Machine, Cardiopulmonary Bypass
More FDA Info for this Device
510(K) Number
K102726
Device Name
Console, Heart-Lung Machine, Cardiopulmonary Bypass
Applicant
MAQUET CARDIOPULMONARY AG
HECHINGER STRASSE 38
HIRRLINGEN 72145 DE
Other 510(k) Applications for this Company
Contact
ROLAND JEHLE
Other 510(k) Applications for this Contact
Regulation Number
870.4220
More FDA Info for this Regulation Number
Classification Product Code
DTQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/21/2010
Decision Date
04/04/2011
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