# K033441: Boston Scientific 6F Runway Guide Catheter

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Nov 21, 2003 after 23 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
Longest line of descent: 1 generation back to K010874 (2001). 1 ancestor in all.
26 later devices descend from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010874: 6F Mach 1, Model 34356-XXX, Boston Scientific Corp (2001) Summary page 1.

## Most influential descendants
- K041151: Kerberos Occluding Guide Catheter and Accessories (2004), 25 descendants of its own
- K080987: Bridgepoint Medical Stingray Device and Accessories (2009), 24 descendants of its own
- K101591: Stingray Orienting Balloon Catheter (2010), 14 descendants of its own
- K102725: Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000, Stingray Guidewire Model M-3004 and M (2011), 11 descendants of its own
- K121763: Multicross Support Catheter (2012), 8 descendants of its own

## Recalls of this device
- Mar 3, 2014 · Class II · Z-1164-2014: The sterile pouch of the devices from this lot may not be completely sealed and sterility may be compromised. The most common adverse health consequence expected from an unsealed pouch is a transient 
- Oct 29, 2004 · Not classified · Z-0454-05: The Runway guide catheter do not meet internal product specifications. Specifically, the affected catheters have exposed or protruding braid wires in the inner lumen of the catheter tip. This conditio

## Indications for use
Boston Scientific Guide Catheters are intended for use in general intravascular and coronary applications. They provide a pathway through which medical instruments, such as balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature.

Source page: https://510kreport.com/device/K033441
Methodology: https://510kreport.com/methodology