Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K192762
Device Classification Name
Ring, Annuloplasty
More FDA Info for this Device
510(K) Number
K192762
Device Name
Ring, Annuloplasty
Applicant
Edwards Lifesciences LLC
One Edwards Way
Irvine, CA 92614 US
Other 510(k) Applications for this Company
Contact
Milinda Mawley
Other 510(k) Applications for this Contact
Regulation Number
870.3800
More FDA Info for this Regulation Number
Classification Product Code
KRH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/30/2019
Decision Date
12/16/2019
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