Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K151513 |
Device Name |
Arrow Endurance Extended Dwell Peripheral Catheter System |
Applicant |
Arrow Internation, Inc. (subsidiary of Teleflex Inc.) |
2400 Bernville Rd |
Reading,
PA
19605
|
|
Applicant Contact |
Tracy Larish |
Correspondent |
THIRD PARTY REVIEW GROUP, LLC |
45 ROCKEFELLER PLAZA |
SUITE 2000 |
NEW YORK,
NY
10111
|
|
Correspondent Contact |
DAVE YUNGVIRT |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 06/04/2015 |
Decision Date | 07/08/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|