Device Classification Name |
catheter, continuous flush
|
510(k) Number |
K050205 |
Device Name |
BENEPHIT BIFURCATED INFUSION CATHETER AND 5FR. INTRODUCER SHEATH |
Applicant |
FLOWMEDICA, INC. |
46563 FREMONT BLVD. |
FREMONT,
CA
94538
|
|
Applicant Contact |
JEFF ELKINS |
Correspondent |
FLOWMEDICA, INC. |
46563 FREMONT BLVD. |
FREMONT,
CA
94538
|
|
Correspondent Contact |
JEFF ELKINS |
Regulation Number | 870.1210
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/28/2005 |
Decision Date | 03/04/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|