Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K003245 |
Device Name |
HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML |
Applicant |
BAXTER HEALTHCARE CORP. |
RT. 120 & WILSON RD. |
ROUND LAKE,
IL
60073
|
|
Applicant Contact |
LINDA COLEMAN |
Correspondent |
BAXTER HEALTHCARE CORP. |
RT. 120 & WILSON RD. |
ROUND LAKE,
IL
60073
|
|
Correspondent Contact |
LINDA COLEMAN |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 10/17/2000 |
Decision Date | 12/04/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|