Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K853348 |
Device Name |
L-CATH EXPANDO CATH |
Applicant |
LUTHER MEDICAL PRODUCTS, INC. |
1940 E. OCCIDENTAL ST. |
SANTA ANA,
CA
92705
|
|
Applicant Contact |
RONALD B LUTHER |
Correspondent |
LUTHER MEDICAL PRODUCTS, INC. |
1940 E. OCCIDENTAL ST. |
SANTA ANA,
CA
92705
|
|
Correspondent Contact |
RONALD B LUTHER |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 08/12/1985 |
Decision Date | 01/09/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|