The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Clotrac Heparinase Test Cartidge (htc) Coagulation Control.
| Device ID | K103314 |
| 510k Number | K103314 |
| Device Name: | CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL |
| Classification | Plasma, Coagulation Control |
| Applicant | MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Contact | Jeffrey L Koll |
| Correspondent | Jeffrey L Koll MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Product Code | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-10 |
| Decision Date | 2010-12-03 |
| Summary: | summary |