Device Classification Name |
catheter, infusion
|
510(k) Number |
K863982 |
Device Name |
VAS-CATH PERICARDIOCENTESIS CATHETER, SET & TRAY |
Applicant |
VAS-CATH OF CANADA LTD. |
2380 TEDLO ST. MISSISSAUGA |
ONTARIO, L5A 3V3,
CA
|
|
Applicant Contact |
KATHERINE H CREWE |
Correspondent |
VAS-CATH OF CANADA LTD. |
2380 TEDLO ST. MISSISSAUGA |
ONTARIO, L5A 3V3,
CA
|
|
Correspondent Contact |
KATHERINE H CREWE |
Regulation Number | 878.4200
|
Classification Product Code |
|
Date Received | 10/14/1986 |
Decision Date | 10/24/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|