# K083269: Crossover

- Pathway: 510(k) (Traditional)
- Applicant: Thomas Medical Products, Inc.
- Decided: Feb 3, 2009 after 90 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K924607 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081341: Reinforced Catheter Introducer System (Rcis), Thomas Medical Products, Inc. (2008) Summary page 1.

## Recalls of this device
- Oct 21, 2009 · Not classified · Z-0120-2010: Sheath may break or fracture which may cause vessel damage or require surgical intervention to retrieve catheter pieces.
- Oct 15, 2009 · Not classified · Z-0087-2010: Cordis has received complaints of stretching or fracture of the sheath shaft during use.

## Indications for use
The CSI is indicated for use in arterial and venous procedures requiring percutaneous introduction of therapeutic or diagnostic intravascular devices or fluids.

Source page: https://510kreport.com/device/K083269
Methodology: https://510kreport.com/methodology