Device Classification Name |
Dilator, Vessel, For Percutaneous Catheterization
|
510(k) Number |
K183036 |
Device Name |
Dilator Sets |
Applicant |
Cook Incorporated |
750 Daniels Way |
Bloomington,
IN
47404
|
|
Applicant Contact |
David Lehr |
Correspondent |
Cook Incorporated |
750 Daniels Way |
Bloomington,
IN
47404
|
|
Correspondent Contact |
David Lehr |
Regulation Number | 870.1310
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/01/2018 |
Decision Date | 12/20/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|