The following data is part of a premarket notification filed by Erika, Inc. with the FDA for Negative Pressure Arterial Blood Line.
| Device ID | K830326 |
| 510k Number | K830326 |
| Device Name: | NEGATIVE PRESSURE ARTERIAL BLOOD LINE |
| Classification | Instrument, Surgical, Disposable |
| Applicant | ERIKA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KDC |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-01 |
| Decision Date | 1983-02-28 |