# K261310: FlexTract Deflectable-Rotational Dilator Sheath Set

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Jul 27, 2026 after 97 days
- Product code: DRE (Dilator, Vessel, For Percutaneous Catheterization)
- Device class: 2
- Regulation: 21 CFR 870.1310
- 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 K061000 (2006). 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)
- K141148: Evolution RL Controlled-Rotation Dilator Sheath Set, Evolution Shortie RL Controlled-Rotation Dilator Sheath Set, Cook Vascular, Inc. (2014) Summary page 5.

## Indications for use
The FlexTract Sheath Set is indicated for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads.

Source page: https://510kreport.com/device/K261310
Methodology: https://510kreport.com/methodology