Device Classification Name |
catheter, continuous flush
|
510(k) Number |
K972518 |
Device Name |
TRANSIT/RAPIDTRANSIT/SPEEDSTER/PROWLER INFUSION CATHETER |
Applicant |
CORDIS NEUROVASCULAR, INC. |
14740 N.W. 60TH AVE. |
MIAMI LAKES,
FL
33014
|
|
Applicant Contact |
Lisa Wells |
Correspondent |
CORDIS NEUROVASCULAR, INC. |
14740 N.W. 60TH AVE. |
MIAMI LAKES,
FL
33014
|
|
Correspondent Contact |
Lisa Wells |
Regulation Number | 870.1210
|
Classification Product Code |
|
Date Received | 07/07/1997 |
Decision Date | 11/04/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|