# K133296: XCATH

- Pathway: 510(k) (Traditional)
- Applicant: Alseal
- Decided: Feb 14, 2014 after 112 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- 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 K032073 (2003). 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)
- K113849: HQS Introducer, Alseal (2012) Summary page 1.
- K121185: Edwards Percutaneous Sheath Introducer, Edwards Lifesciences, LLC (2012) Summary page 1.

## Indications for use
XCath (model 2064-XC) is intended to be inserted into the EQS Introducer (model 2064-HQS) to establish multiple and simultaneous conduits through the same vascular access (previously established by the I-QS introducer). The whole XCath / HQS allows insertion of several endlovascular devices at the same time while minimizing blood loss associated with such insertions.

Source page: https://510kreport.com/device/K133296
Methodology: https://510kreport.com/methodology