Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K970864 |
FOIA Releasable 510(k) |
K970864
|
Device Name |
ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS |
Applicant |
ARROW INTL., INC. |
3000 BERNVILLE RD. |
READING,
PA
19605
|
|
Applicant Contact |
THOMAS D NICKEL |
Correspondent |
ARROW INTL., INC. |
3000 BERNVILLE RD. |
READING,
PA
19605
|
|
Correspondent Contact |
THOMAS D NICKEL |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 03/10/1997 |
Decision Date | 10/17/1997 |
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
|
|
|