The following data is part of a premarket notification filed by Medtronic Hemotec, Inc. with the FDA for Heparin Assay Cartridges And Controls.
| Device ID | K944115 |
| 510k Number | K944115 |
| Device Name: | HEPARIN ASSAY CARTRIDGES AND CONTROLS |
| Classification | Protamine Sulphate |
| Applicant | MEDTRONIC HEMOTEC, INC. 7103 S. REVERE PKWY. Englewood, CO 80112 |
| Contact | Robert F Baugh |
| Correspondent | Robert F Baugh MEDTRONIC HEMOTEC, INC. 7103 S. REVERE PKWY. Englewood, CO 80112 |
| Product Code | GFT |
| CFR Regulation Number | 864.7525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-23 |
| Decision Date | 1995-03-24 |