Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K093050 |
Device Name |
ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520 |
Applicant |
ARROW INTL., INC. |
2400 BERNVILLE RD. |
READING,
PA
19605
|
|
Applicant Contact |
CHRISTINE FORD |
Correspondent |
ARROW INTL., INC. |
2400 BERNVILLE RD. |
READING,
PA
19605
|
|
Correspondent Contact |
CHRISTINE FORD |
Regulation Number | 870.1250
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/30/2009 |
Decision Date | 12/18/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|