The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Heparin Dose Response Controls, Model 306-20 Por.
| Device ID | K043080 |
| 510k Number | K043080 |
| Device Name: | HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR |
| Classification | Analyzer, Heparin, Automated |
| Applicant | MEDTRONIC VASCULAR 7611 NORTHLAND DR. Minneapolis, MN 55428 |
| Contact | Bruce Backlund |
| Correspondent | Bruce Backlund MEDTRONIC VASCULAR 7611 NORTHLAND DR. Minneapolis, MN 55428 |
| Product Code | JOX |
| CFR Regulation Number | 864.5680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-08 |
| Decision Date | 2004-12-03 |
| Summary: | summary |