The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrow Large-bore Dual Lumen Hemodialysis Kit.
| Device ID | K895417 |
| 510k Number | K895417 |
| Device Name: | ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT |
| Classification | Catheter, Subclavian |
| Applicant | ARROW INTL., INC. P.O. BOX 6306 HILL AND GEORGE AVENUES Reading, PA 19610 |
| Contact | Thomas D Nickel |
| Correspondent | Thomas D Nickel ARROW INTL., INC. P.O. BOX 6306 HILL AND GEORGE AVENUES Reading, PA 19610 |
| Product Code | LFJ |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-01 |
| Decision Date | 1990-01-03 |