The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Purple/black Heparin Assay Control.
| Device ID | K042206 |
| 510k Number | K042206 |
| Device Name: | PURPLE/BLACK HEPARIN ASSAY CONTROL |
| Classification | Plasma, Coagulation Control |
| Applicant | MEDTRONIC VASCULAR 7611 NORTHLAND DR. Minneapolis, MN 55428 |
| Contact | Dawn Stenstrom |
| Correspondent | Dawn Stenstrom MEDTRONIC VASCULAR 7611 NORTHLAND DR. Minneapolis, MN 55428 |
| Product Code | GGN |
| Subsequent Product Code | GFT |
| Subsequent Product Code | JOX |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-16 |
| Decision Date | 2004-10-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994923336 | K042206 | 000 |