Device Classification Name |
catheter, intravascular, diagnostic
|
510(k) Number |
K233975 |
Device Name |
Zoom 6F Insert Catheters |
Applicant |
Imperative Care, Inc. |
1359 Dell Avenue |
Campbell,
CA
95008
|
|
Applicant Contact |
Nguyen Teri |
Correspondent |
Imperative Care, Inc. |
1359 Dell Avenue |
Campbell,
CA
95008
|
|
Correspondent Contact |
Nguyen Teri |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 12/15/2023 |
Decision Date | 04/02/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|