Device Classification Name |
Catheter, Ultrasound, Intravascular
|
510(k) Number |
K132133 |
Device Name |
CG+ ARROW JACC POWERED BY ARROW VPS STYLET |
Applicant |
ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) |
2400 BERNVILLE RD. |
READING,
PA
19605
|
|
Applicant Contact |
JULIE LAWSON |
Correspondent |
ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) |
2400 BERNVILLE RD. |
READING,
PA
19605
|
|
Correspondent Contact |
JULIE LAWSON |
Regulation Number | 870.1200
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/11/2013 |
Decision Date | 09/26/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|