Device Classification Name |
Catheter, Pressure Monitoring, Cardiac
|
510(k) Number |
K190473 |
Device Name |
ACIST RXi System and Navvus II Catheter |
Applicant |
ACIST Medical Systems, Inc. |
7905 Fuller Road |
Eden Prairie,
MN
55344
|
|
Applicant Contact |
Sherri Mellingen |
Correspondent |
ACIST Medical Systems, Inc. |
7905 Fuller Road |
Eden Prairie,
MN
55344
|
|
Correspondent Contact |
Sherri Mellingen |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 02/27/2019 |
Decision Date | 09/13/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|