The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrow Brachial Central Venous Cath-kit W/16ga & Ec.
| Device ID | K854137 |
| 510k Number | K854137 |
| Device Name: | ARROW BRACHIAL CENTRAL VENOUS CATH-KIT W/16GA & EC |
| Classification | Catheter, Percutaneous |
| Applicant | ARROW INTL., INC. P.O. BOX 6306 HILL AND GEORGE AVENUES Reading, PA 19610 |
| Contact | Ronald P Citron |
| Correspondent | Ronald P Citron ARROW INTL., INC. P.O. BOX 6306 HILL AND GEORGE AVENUES Reading, PA 19610 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-10 |
| Decision Date | 1985-12-03 |