The following data is part of a premarket notification filed by Argon Medical Corp. with the FDA for Arterial Line Kit.
| Device ID | K780871 |
| 510k Number | K780871 |
| Device Name: | ARTERIAL LINE KIT |
| Classification | Gauze/sponge, Internal, X-ray Detectable |
| Applicant | ARGON MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GDY |
| CFR Regulation Number | 878.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-05-30 |
| Decision Date | 1978-06-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20886333224184 | K780871 | 000 |
| 20886333215649 | K780871 | 000 |
| 20886333215632 | K780871 | 000 |
| 20886333215625 | K780871 | 000 |
| 20886333215618 | K780871 | 000 |
| 20886333215601 | K780871 | 000 |
| 20886333215595 | K780871 | 000 |
| 20886333215588 | K780871 | 000 |
| 20886333215571 | K780871 | 000 |
| 20886333215564 | K780871 | 000 |
| 20886333215557 | K780871 | 000 |
| 20886333215540 | K780871 | 000 |
| 20886333215533 | K780871 | 000 |
| 20886333215656 | K780871 | 000 |
| 20886333215663 | K780871 | 000 |
| 20886333215670 | K780871 | 000 |
| 20886333221091 | K780871 | 000 |
| 20886333215786 | K780871 | 000 |
| 20886333215779 | K780871 | 000 |
| 20886333215762 | K780871 | 000 |
| 20886333215755 | K780871 | 000 |
| 20886333215748 | K780871 | 000 |
| 20886333215731 | K780871 | 000 |
| 20886333215724 | K780871 | 000 |
| 20886333215717 | K780871 | 000 |
| 20886333215700 | K780871 | 000 |
| 20886333215694 | K780871 | 000 |
| 20886333215687 | K780871 | 000 |
| 20886333212884 | K780871 | 000 |