Device Classification Name |
catheter, intravascular, therapeutic, long-term greater than 30 days
|
510(k) Number |
K963257 |
Device Name |
PERIPHERALLY INSERTED MEDLINE CATHETER |
Applicant |
ARROW INTL., INC. |
P.O. BOX 12888 |
3000 BERNVILLE RD |
READING,
PA
19612
|
|
Applicant Contact |
THOMAS D NICKEL |
Correspondent |
ARROW INTL., INC. |
P.O. BOX 12888 |
3000 BERNVILLE RD |
READING,
PA
19612
|
|
Correspondent Contact |
THOMAS D NICKEL |
Regulation Number | 880.5970
|
Classification Product Code |
|
Date Received | 08/19/1996 |
Decision Date | 03/04/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|