# K212784: TightRail Guardian Motorized Dilator Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Spectranetics, Inc.
- Decided: Aug 24, 2022 after 357 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: 6 generations back to K061000 (2006). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150360: TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath, Spectranetics, Inc. (2015) Summary page 4.
- K161333: TightRail Sub-C Rotating Dilator Sheath, Spectranetics, Inc. (2016) Summary page 4.

## Most influential descendants
- 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) (2022), 0 descendants of its own

## 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/K212784
Methodology: https://510kreport.com/methodology