The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrow High Flow Fluid Adminsitration Set W/blood Filter & Extension Set.
| Device ID | K953746 |
| 510k Number | K953746 |
| Device Name: | ARROW HIGH FLOW FLUID ADMINSITRATION SET W/BLOOD FILTER & EXTENSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | ARROW INTL., INC. 3000 BERNVILLE RD. Reading, PA 19605 |
| Contact | Thomas D Nickel |
| Correspondent | Thomas D Nickel ARROW INTL., INC. 3000 BERNVILLE RD. Reading, PA 19605 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-10 |
| Decision Date | 1996-01-26 |