The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Heparin Dose Response Cartridge.
| Device ID | K102953 |
| 510k Number | K102953 |
| Device Name: | HEPARIN DOSE RESPONSE CARTRIDGE |
| Classification | Analyzer, Heparin, Automated |
| Applicant | MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Contact | Jeffery L Koll |
| Correspondent | Jeffery L Koll MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Product Code | JOX |
| CFR Regulation Number | 864.5680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-04 |
| Decision Date | 2010-11-04 |
| Summary: | summary |