# K103386: Medtronic Vascular - Hub Material Modification to the 5F and 8F Launcher (R) Guide Catheters

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Feb 11, 2011 after 85 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

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

## Predicates on the family tree (from the FDA summary)
- K030779: 5F Medtronic Launcher Guide Catheter, Medtronic Vascular (2003) Summary page 1.
- K023402: 8F Launcher Guide Catheter, Medtronic Vascular (2002) Summary page 1.

## Most influential descendants
- K132673: 5F & 6F Launcher Guide Catheter, 5F Sherpa Active NX Guide Catheter, 6F Z4 Guiding Catheter (2013), 0 descendants of its own

## Recalls of this device
- Jun 12, 2013 · Class II · Z-1564-2013: Medtronic has identified a labeling issue for 24 units of the Launcher coronary Guide Catheter. The two affected catheter lots are mislabeled and do not accurately reflect the catheters contained with

## Indications for use
The Medtronic Guide Catheters are intended to be used in the coronary or the peripheral system; and are designed to provide a pathway through which therapeutic devices are introduced.

Source page: https://510kreport.com/device/K103386
Methodology: https://510kreport.com/methodology