# K023402: 8F Launcher Guide Catheter

- Pathway: 510(k) (Special)
- Applicant: Medtronic Vascular
- Decided: Nov 6, 2002 after 27 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 18 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K981198 (1998). 4 ancestors in all.
8 later devices descend from it; 6 cite it directly.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022764: 7F Launcher Guide Catheter, Medtronic Vascular (2002)

## Most influential descendants
- K060418: 8F Sherpa NX Guide Catheter (2006), 3 descendants of its own
- K062420: 5F Sherpa Active NX Guide Catheter (2006), 2 descendants of its own
- K103386: Medtronic Vascular - Hub Material Modification to the 5F and 8F Launcher (R) Guide Catheters (2011), 1 descendant of its own
- K091188: Asahi Zenyteex Guiding Catheter (2010), 1 descendant of its own
- K141529: Alviguide Blue+ Interventional Cardiology Guiding Catheter (2014), 0 descendants of its own

## Recalls of this device
- Apr 5, 2006 · Not classified · Z-0981-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-0982-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-0983-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-0984-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-0986-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-0987-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-0992-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-0993-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-0994-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-0985-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-0988-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-0989-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-0990-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-0991-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-0995-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1042-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1041-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1043-06: Potential for non-sterility due to loss of package integrity

## Indications for use
The Medtronic® Launcher™ Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Launcher catheter is intended to be used in the coronary or peripheral vascular system.

Source page: https://510kreport.com/device/K023402
Methodology: https://510kreport.com/methodology