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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20801902212225 | K895417 | 000 |
| 40801902111720 | K895417 | 000 |
| 50801902101797 | K895417 | 000 |
| 20801902096207 | K895417 | 000 |
| 20801902005810 | K895417 | 000 |
| 20801902138884 | K895417 | 000 |
| 20801902100096 | K895417 | 000 |
| 20801902139096 | K895417 | 000 |
| 20801902001133 | K895417 | 000 |
| 20801902096078 | K895417 | 000 |
| 00801902031365 | K895417 | 000 |
| 20801902190110 | K895417 | 000 |
| 20801902190165 | K895417 | 000 |
| 20801902005575 | K895417 | 000 |
| 40801902123105 | K895417 | 000 |
| 40801902123112 | K895417 | 000 |
| 20801902001188 | K895417 | 000 |
| 20801902140894 | K895417 | 000 |
| 30801902029240 | K895417 | 000 |
| 20801902096245 | K895417 | 000 |
| 10801902001099 | K895417 | 000 |
| 10801902001129 | K895417 | 000 |
| 30801902001031 | K895417 | 000 |
| 30801902005572 | K895417 | 000 |
| 30801902005794 | K895417 | 000 |
| 30801902005817 | K895417 | 000 |
| 30801902096068 | K895417 | 000 |
| 30801902096075 | K895417 | 000 |
| 30801902100109 | K895417 | 000 |
| 30801902100130 | K895417 | 000 |
| 70801902123113 | K895417 | 000 |
| 70801902123106 | K895417 | 000 |
| 10801902005790 | K895417 | 000 |
| 10801902096064 | K895417 | 000 |
| 20801902123101 | K895417 | 000 |
| 20801902123118 | K895417 | 000 |
| 50801902005576 | K895417 | 000 |
| 50801902005798 | K895417 | 000 |
| 60801902123109 | K895417 | 000 |
| 60801902123116 | K895417 | 000 |
| 30801902100147 | K895417 | 000 |