Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K163660
Device Classification Name
Catheters, Transluminal Coronary Angioplasty, Percutaneous
More FDA Info for this Device
510(K) Number
K163660
Device Name
Catheters, Transluminal Coronary Angioplasty, Percutaneous
Applicant
BIOTRONIK, INC.
6024 JEAN ROAD
LAKE OSWEGO, OR 97035 US
Other 510(k) Applications for this Company
Contact
Jon Brumbaugh
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LOX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/27/2016
Decision Date
01/26/2017
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