# K203487: Drakon and Sequre Microcatheters

- Pathway: 510(k) (Special)
- Applicant: Accurate Medical Therapeutics, Ltd.
- Decided: Dec 11, 2020 after 14 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: 5 generations back to K915414 (1992). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
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.

## Most influential descendants
- K231293: Drakon™ and Sequre® Microcatheters (2023), 0 descendants of its own

## 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 intraarterial therapy and infusion of embolic materials. The Drakon™ and Sequre® microcatheters should not be used in cerebral vessels.

Source page: https://510kreport.com/device/K203487
Methodology: https://510kreport.com/methodology