Device Classification Name |
catheter, septostomy
|
510(k) Number |
K801031 |
Device Name |
BLADE SEPTOSTOMY CATHETER |
Applicant |
COOK, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
COOK, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 870.5175
|
Classification Product Code |
|
Date Received | 05/01/1980 |
Decision Date | 07/28/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|