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 |