Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K200324 |
Device Name |
NHancer Rx |
Applicant |
IMDS Operations B.V. |
Ceintuurbaan Noord 150 |
Roden,
NL
9301 NA
|
|
Applicant Contact |
E Schulting |
Correspondent |
IMDS Operations B.V. |
Ceintuurbaan Noord 150 |
Roden,
NL
9301 NA
|
|
Correspondent Contact |
E. Schulting |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 02/10/2020 |
Decision Date | 08/06/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|