| Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
| 510(k) Number |
K874582 |
| Device Name |
DESERET SPLITTABLE CATHETER |
| Applicant |
| Deseret Medical, Inc. |
| 9450 S. State St. |
|
Sandy,
UT
84070
|
|
| Applicant Contact |
E. F CLEARY |
| Correspondent |
| Deseret Medical, Inc. |
| 9450 S. State St. |
|
Sandy,
UT
84070
|
|
| Correspondent Contact |
E. F CLEARY |
| Regulation Number | 880.5200 |
| Classification Product Code |
|
| Date Received | 11/09/1987 |
| Decision Date | 12/29/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|