# K022138: Spectranetics 0.035 Support Catheter, Model 518-028

- Pathway: 510(k) (Traditional)
- Applicant: Spectranetics Corp.
- Decided: Sep 23, 2002 after 83 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K935425 (1994). 2 ancestors in all.
108 later devices descend from it; 5 cite it directly.
1 of 111 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991059: Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018 Support Catheter, Model 518-017, Spectranetics Corp. (1999) Summary page 1.
- K935425: Metronic Buchbinder Envoy Percutaneous Catheters, Medtronics Interventional Vascular (1994) Summary page 1.

## Most influential descendants
- K033678: Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035, 518-036, 518-037 and 518-038 (2004), 106 descendants of its own
- K052258: Vascular Solutions Skyway Support Catheter (2005), 80 descendants of its own
- K072750: Spectranetics Quick-Cross SUPPORT2 Catheters, Models 518-065 and 518-066 (2007), 66 descendants of its own
- K070372: Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model 5610 (2007), 44 descendants of its own
- K082337: Minnie Support Catheter (2009), 35 descendants of its own

## Indications for use
The Spectranetics Support Catheters are designed for use in the vascular system. The catheters are intended to support a guidewire during access of the vasculature, allow for exchange of guidewires, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

Source page: https://510kreport.com/device/K022138
Methodology: https://510kreport.com/methodology