Device Classification Name |
Catheter, Embolectomy
|
510(k) Number |
K970762 |
Device Name |
DUAL LUMEN EMBOLECTOMY CATHETER |
Applicant |
APPLIED MEDICAL RESOURCES |
26051 MERIT CIRCLE |
BUILDING 104 |
LAGUNA HILLS,
CA
92653
|
|
Applicant Contact |
HOWARD V ROWE |
Correspondent |
APPLIED MEDICAL RESOURCES |
26051 MERIT CIRCLE |
BUILDING 104 |
LAGUNA HILLS,
CA
92653
|
|
Correspondent Contact |
HOWARD V ROWE |
Regulation Number | 870.5150
|
Classification Product Code |
|
Date Received | 03/03/1997 |
Decision Date | 03/28/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|