Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K935425 |
Device Name |
METRONIC BUCHBINDER ENVOY PERCUTANEOUS CATHETERS |
Applicant |
MEDTRONICS INTERVENTIONAL VASCULAR |
9410 CARROLL PARK DR. |
SAN DIEGO,
CA
92121 -2256
|
|
Applicant Contact |
TIMOTHY J JOHNSON |
Correspondent |
MEDTRONICS INTERVENTIONAL VASCULAR |
9410 CARROLL PARK DR. |
SAN DIEGO,
CA
92121 -2256
|
|
Correspondent Contact |
TIMOTHY J JOHNSON |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 11/10/1993 |
Decision Date | 04/26/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|