Device Classification Name |
Catheter, Intravascular, Diagnostic
|
510(k) Number |
K925813 |
Device Name |
DIAGNOSTIC INTRAVASCULAR CATHETER |
Applicant |
TARGET THERAPEUTICS |
47201 LAKEVIEW BLVD. |
P.O. BOX 5120 |
FREEMONT,
CA
94538
|
|
Applicant Contact |
LARAINE PANGELINA |
Correspondent |
TARGET THERAPEUTICS |
47201 LAKEVIEW BLVD. |
P.O. BOX 5120 |
FREEMONT,
CA
94538
|
|
Correspondent Contact |
LARAINE PANGELINA |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 11/17/1992 |
Decision Date | 03/23/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|