The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrow-geiss Percutaneous Tpn Kit.
| Device ID | K844080 |
| 510k Number | K844080 |
| Device Name: | ARROW-GEISS PERCUTANEOUS TPN KIT |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| 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 | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-19 |
| Decision Date | 1985-04-17 |