# K223472: TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013)

- Pathway: 510(k) (Special)
- Applicant: Spectranetics, Inc.
- Decided: Dec 15, 2022 after 28 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: 7 generations back to K061000 (2006). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212784: TightRail Guardian Motorized Dilator Sheath, Spectranetics, Inc. (2022) Summary page 4.

## Indications for use
The TightRail Guardian motorized dilator sheath is intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads.

Source page: https://510kreport.com/device/K223472
Methodology: https://510kreport.com/methodology