| Device Classification Name |
Cannula, Catheter
|
| 510(k) Number |
K880771 |
| Device Name |
MEDSURG 7 FR. DUAL LUMEN CENTRAL VEIN CATH SYSTEM |
| Applicant |
| Medsurg Industries, Inc. |
| 251 Exchange Pl. |
|
Herndon,
VA
20170
|
|
| Applicant Contact |
TOM BONNER |
| Correspondent |
| Medsurg Industries, Inc. |
| 251 Exchange Pl. |
|
Herndon,
VA
20170
|
|
| Correspondent Contact |
TOM BONNER |
| Regulation Number | 870.1300 |
| Classification Product Code |
|
| Date Received | 02/26/1988 |
| Decision Date | 05/03/1988 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|