# K103367: Seeker Crossing Support Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Bard Peripheral Vascular, Inc.
- Decided: Dec 8, 2010 after 22 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K133539: Total Across (2014), 2 descendants of its own
- K183305: Crossing Support Catheter (2019), 0 descendants of its own
- K180889: Tractus Crossing Support Catheter (2018), 0 descendants of its own

## Recalls of this device
- Apr 16, 2018 · Class II · Z-1803-2018: Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. The bacterial endotoxin levels for the catheters are within accepta
- Apr 16, 2018 · Class II · Z-1802-2018: Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. The bacterial endotoxin levels for the catheters are within accepta

## Indications for use
The Seekerm Crossing Support Catheters are recommended for guidewire exchange and infusion devices designed for use in the peripheral vascular system. The catheters are intended to support a guidewire during access into the vasculature, allow for guidewire exchanges, and provide a passage for delivery of saline solutions and/or diagnostic contrast agents.

Source page: https://510kreport.com/device/K103367
Methodology: https://510kreport.com/methodology