Device Classification Name |
Catheter, Peripheral, Atherectomy
|
510(k) Number |
K960970 |
Device Name |
POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER,MODEL 3030C,LF140 CATHETER,MODEL 3040C,PUMP SET 3020P |
Applicant |
POSSIS MEDICAL, INC. |
2905 NORTHWEST BLVD. |
MINNEAPOLIS,
MN
55441 -2644
|
|
Applicant Contact |
JAMES D GUSTAFSON |
Correspondent |
POSSIS MEDICAL, INC. |
2905 NORTHWEST BLVD. |
MINNEAPOLIS,
MN
55441 -2644
|
|
Correspondent Contact |
JAMES D GUSTAFSON |
Regulation Number | 870.4875
|
Classification Product Code |
|
Date Received | 03/11/1996 |
Decision Date | 12/03/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|