Device Classification Name |
introducer, catheter
|
510(k) Number |
K924562 |
Device Name |
CATHETER INTRODUCER |
Applicant |
LUTHER MEDICAL PRODUCTS, INC. |
14332 CHAMBERS RD. |
TUSTIN,
CA
92780 -6912
|
|
Applicant Contact |
BARBARA C LUTHER |
Correspondent |
LUTHER MEDICAL PRODUCTS, INC. |
14332 CHAMBERS RD. |
TUSTIN,
CA
92780 -6912
|
|
Correspondent Contact |
BARBARA C LUTHER |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 09/09/1992 |
Decision Date | 02/25/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|