# K231293: Drakon™ and Sequre® Microcatheters

- Pathway: 510(k) (Special)
- Applicant: Accurate Medical Therapeutics
- Decided: Jun 1, 2023 after 28 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K915414 (1992). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173430: SeQure® NF and SeQure® Microcatheters, Accurate Medical Therapeutics, Ltd. (2018) Summary page 4.
- K202797: Drakon and Sequre Microcatheters, Accurate Medical Therapeutics, Ltd. (2020) Summary page 4.
- K203487: Drakon and Sequre Microcatheters, Accurate Medical Therapeutics, Ltd. (2020) Summary page 4.

## Indications for use
The Drakon™ and SeQure® microcatheters are intended for the infusion of contrast media into all peripheral vessels. The Drakon™ and SeQure® microcatheters are also intended for drug infusion in intra-arterial therapy and infusion of embolic materials. The Drakon™ and the SeQure® microcatheters should not be used in cerebral vessels.

Source page: https://510kreport.com/device/K231293
Methodology: https://510kreport.com/methodology