Device Classification Name |
catheter, continuous flush
|
510(k) Number |
K210838 |
Device Name |
PROWLER SELECT PLUS; PROWLER EX |
Applicant |
Medos International SARL |
Chemin-Blanc 38 |
Le Locle,
CH
2400
|
|
Applicant Contact |
Samuel Shimp |
Correspondent |
Cerenovus |
6303 Blue Lagoon Drive; Suite 315 |
Miami,
FL
33126
|
|
Correspondent Contact |
Samuel Shimp |
Regulation Number | 870.1210
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/22/2021 |
Decision Date | 08/25/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|