Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K143463
Device Classification Name
Pacemaker Lead Adaptor
More FDA Info for this Device
510(K) Number
K143463
Device Name
Pacemaker Lead Adaptor
Applicant
Oscor Inc.
3816 De Soto Boulevard
Palm Harbor, FL 34683 US
Other 510(k) Applications for this Company
Contact
Dorit Segal
Other 510(k) Applications for this Contact
Regulation Number
870.3620
More FDA Info for this Regulation Number
Classification Product Code
DTD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/04/2014
Decision Date
03/19/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact