Device Classification Name |
introducer, catheter
|
510(k) Number |
K122854 |
Device Name |
ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER |
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 | 870.1340
|
Classification Product Code |
|
Date Received | 09/18/2012 |
Decision Date | 01/04/2013 |
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
|
|
|