Device Classification Name |
catheter, intravascular, therapeutic, long-term greater than 30 days
|
510(k) Number |
K123759 |
Device Name |
CG+ ARROW PICC POWERED BY ARROW VPS STYLET |
Applicant |
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, |
2400 BERNVILLE ROAD |
READING,
PA
19605
|
|
Applicant Contact |
ELIZABETH DUNCAN |
Correspondent |
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, |
2400 BERNVILLE ROAD |
READING,
PA
19605
|
|
Correspondent Contact |
ELIZABETH DUNCAN |
Regulation Number | 880.5970
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/07/2012 |
Decision Date | 01/03/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|