Device Classification Name |
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
|
510(k) Number |
K182586 |
Device Name |
DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure Port |
Applicant |
Medtronic, Inc. |
8200 Coral Street NE |
Mounds View,
MN
55125
|
|
Applicant Contact |
Linda L. Julia Davila |
Correspondent |
Medtronic, Inc. |
8200 Coral Street NE |
Mounds View,
MN
55125
|
|
Correspondent Contact |
Linda L. Julia Davila |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 09/20/2018 |
Decision Date | 10/19/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|