Device Classification Name |
Catheter, Angioplasty, Peripheral, Transluminal
|
510(k) Number |
K971516 |
Device Name |
CORDIS POWERFLEX PLUS PTA BALLOON CATHETER |
Applicant |
CORDIS CORP. |
14201 N.W. 60TH AVE. |
MIAMI LAKES,
FL
33014
|
|
Applicant Contact |
MIRJAM BARBOZA |
Correspondent |
CORDIS CORP. |
14201 N.W. 60TH AVE. |
MIAMI LAKES,
FL
33014
|
|
Correspondent Contact |
MIRJAM BARBOZA |
Regulation Number | 870.1250 |
Classification Product Code |
|
Date Received | 04/28/1997 |
Decision Date | 07/23/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|