Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K192712 |
Device Name |
Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter |
Applicant |
Medtronic Inc |
Parkmore Business Park West |
Galway,
IE
|
|
Applicant Contact |
Sharon Fahy |
Correspondent |
Medtronic Inc |
Parkmore Business Park West |
Galway,
IE
|
|
Correspondent Contact |
Nicola Reidy |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 09/27/2019 |
Decision Date | 08/03/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|