Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K223648 |
Device Name |
Cook® Spectrum® 2 MRC Central Venous Catheter |
Applicant |
Cook Advanced Technologies |
1400 Cumberland Avenue |
West Lafayette,
IN
47906
|
|
Applicant Contact |
Matthew Waninger |
Correspondent |
Cook Advanced Technologies |
1400 Cumberland Avenue |
West Lafayette,
IN
47906
|
|
Correspondent Contact |
Matthew Waninger |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 12/06/2022 |
Decision Date | 02/03/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|