Class Class II
Drakon™ and Sequre® Microcatheters (K231293)
Description
Drakon™ and Sequre® Microcatheters by Accurate Medical Therapeutics, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK231293
Clearance Date2023-06-01
Clearance TypeSpecial
Product CodeDQO
Regulation Number870.1200
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K231293
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Drakon™ and Sequre® Microcatheters (K231293) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K203487 | Drakon and Sequre Microcatheters | Accurate Medical Therapeutics, Ltd. | 2020 |
| K202797 | Drakon and Sequre Microcatheters | Accurate Medical Therapeutics, Ltd. | 2020 |
| K173430 | SeQure® NF and SeQure® Microcatheters | Accurate Medical Therapeutics, Ltd. | 2018 |
Trace the full predicate network for K231293
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.