Device Classification Name |
device, percutaneous retrieval
|
510(k) Number |
K222083 |
Device Name |
LimFlow V-Ceiver |
Applicant |
LimFlow Inc. |
3031 Tisch Way - 110 Plaza West |
San Jose,
CA
95128
|
|
Applicant Contact |
Zachary Woodson |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 870.5150
|
Classification Product Code |
|
Date Received | 07/15/2022 |
Decision Date | 08/09/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|