Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K861479 |
Device Name |
CAVAFIX, CENTRAL VENOUS CATHETER KIT |
Applicant |
BURRON MEDICAL PRODUCTS, INC. |
824 TWELFTH AVE. |
BETHLEHEM,
PA
18018
|
|
Applicant Contact |
TRACEY YAKABOW |
Correspondent |
BURRON MEDICAL PRODUCTS, INC. |
824 TWELFTH AVE. |
BETHLEHEM,
PA
18018
|
|
Correspondent Contact |
TRACEY YAKABOW |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 04/22/1986 |
Decision Date | 07/01/1986 |
Decision |
Substantially Equivalent - With Drug
(SESD) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|