Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K221846 |
Device Name |
Artix Ballon Guiding Sheath |
Applicant |
Inari Medical |
6001 Oak Canyon |
Suite 100 |
Irvine,
CA
92618
|
|
Applicant Contact |
Elllen Nguyen |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 06/24/2022 |
Decision Date | 07/11/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|