Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K021723 |
Device Name |
SHEATH ADAPTER, MODEL SA-09847 |
Applicant |
ARROW INTL., INC. |
2400 BERNVILLE RD. |
READING,
PA
19605
|
|
Applicant Contact |
BRANDON EPTING |
Correspondent |
ARROW INTL., INC. |
2400 BERNVILLE RD. |
READING,
PA
19605
|
|
Correspondent Contact |
BRANDON EPTING |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 05/24/2002 |
Decision Date | 08/08/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|