The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Emergency Infusion Device.
| Device ID | K840455 |
| 510k Number | K840455 |
| Device Name: | EMERGENCY INFUSION DEVICE |
| Classification | Introducer, Catheter |
| Applicant | ARROW INTL., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-02 |
| Decision Date | 1984-05-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902101526 | K840455 | 000 |
| 20801902207122 | K840455 | 000 |
| 30801902207105 | K840455 | 000 |
| 20801902193494 | K840455 | 000 |
| 20801902194637 | K840455 | 000 |
| 10801902005189 | K840455 | 000 |
| 20801902001348 | K840455 | 000 |
| 30801902001369 | K840455 | 000 |
| 30801902001376 | K840455 | 000 |
| 30801902005183 | K840455 | 000 |
| 30801902009761 | K840455 | 000 |
| 30801902043857 | K840455 | 000 |
| 30801902098055 | K840455 | 000 |
| 30801902098406 | K840455 | 000 |
| 20801902100515 | K840455 | 000 |
| 30801902100529 | K840455 | 000 |
| 30801902101519 | K840455 | 000 |
| 20801902207115 | K840455 | 000 |