| Device Classification Name |
Catheter, Subclavian
|
| 510(k) Number |
K844336 |
| Device Name |
VAS-CATH PARALLEL DUAL LUMAN JUGULAR CANNUAL CATH |
| Applicant |
| Vas-Cath of Canada , Ltd. |
| 2380 Tedlo St. Mississauga |
|
Ontario, L5a 3v3,
CA
|
|
| Applicant Contact |
KAMAL KALWANI |
| Correspondent |
| Vas-Cath of Canada , Ltd. |
| 2380 Tedlo St. Mississauga |
|
Ontario, L5a 3v3,
CA
|
|
| Correspondent Contact |
KAMAL KALWANI |
| Regulation Number | 876.5540 |
| Classification Product Code |
|
| Date Received | 11/08/1984 |
| Decision Date | 03/13/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Gastroenterology/Urology
|
| 510k Review Panel |
Gastroenterology/Urology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|