Device Classification Name |
catheter, continuous flush
|
510(k) Number |
K043538 |
Device Name |
HYPERTRANSIT INFUSION CATHETER |
Applicant |
CORDIS NEUROVASCULAR, INC. |
14000 N.W. 57TH CT. |
MIAMI LAKES,
FL
33014
|
|
Applicant Contact |
MARITZA CELAYA |
Correspondent |
CORDIS NEUROVASCULAR, INC. |
14000 N.W. 57TH CT. |
MIAMI LAKES,
FL
33014
|
|
Correspondent Contact |
MARITZA CELAYA |
Regulation Number | 870.1210
|
Classification Product Code |
|
Date Received | 12/22/2004 |
Decision Date | 04/18/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|