# K211679: Xtractor device

- Pathway: 510(k) (Traditional)
- Applicant: Xcardia Innovation, Ltd.
- Decided: Feb 17, 2022 after 261 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: 4 generations back to K061000 (2006). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140047: Lexiconture Mechanical Dilator Sheath Set, Spectranetics Corp. (2014) Summary page 4.
- K142546: TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath, Spectranetics, Inc. (2014) Summary page 4.

## Indications for use
The Xtractor™ device is intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads, indwelling catheters, and foreign objects.

Source page: https://510kreport.com/device/K211679
Methodology: https://510kreport.com/methodology