# K103314: Clotrac Heparinase Test Cartidge (HTC) Coagulation Control

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Dec 3, 2010 after 23 days
- Product code: GGN (Plasma, Coagulation Control)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K902081 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042175: Heparinase HR Act Control, Model 550-12, Medtronic Vascular (2004) Summary page 1.

## Indications for use
The CLOTtrac® Heparinase Test Cartridge (HTC) Coagulation Control is used to verify the performance of the ACT instrument and the Heparinase (HR-HTC) cartridges.

Source page: https://510kreport.com/device/K103314
Methodology: https://510kreport.com/methodology