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 |