# K021256: Z3 Guide Catheter - Pathway: 510(k) (Special) - Applicant: Medtronic Vascular - Decided: May 17, 2002 after 28 days - Product code: DQY (Catheter, Percutaneous) - Device class: 2 - Regulation: 21 CFR 870.1250 - Recalls of this device: 52 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 1 generation back to K981198 (1998). 2 ancestors in all. 24 later devices descend from it; 7 cite it directly. 3 of 27 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K981198: Medtronic Zuma Guiding Catheter, Medtronics Interventional Vascular (1998) Summary page 1. - K010579: Stent Support Guide Catheter, Medtronic Vascular (2001) Summary page 1. ## Most influential descendants - K022764: 7F Launcher Guide Catheter (2002), 11 descendants of its own - K030779: 5F Medtronic Launcher Guide Catheter (2003), 10 descendants of its own - K042489: 6F Z4 Guide Catheter (2004), 8 descendants of its own - K023402: 8F Launcher Guide Catheter (2002), 8 descendants of its own - K060418: 8F Sherpa NX Guide Catheter (2006), 3 descendants of its own ## Recalls of this device - Jan 15, 2021 · Class II · Z-1248-2021: Sterility may be compromised due to an unsealed pouch - Jan 15, 2021 · Class II · Z-1246-2021: Sterility may be compromised due to an unsealed pouch - Jan 15, 2021 · Class II · Z-1245-2021: Sterility may be compromised due to an unsealed pouch - Jan 15, 2021 · Class II · Z-1247-2021: Sterility may be compromised due to an unsealed pouch - Oct 13, 2014 · Class II · Z-0205-2015: Two reports have been received on the 6F launcher Guide Catheter lot (Model Number LA6JR40K; lot No 0007244836} for incorrect usable length of the Guide Catheter. It was reported that the catheters ha - 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 - Apr 5, 2006 · Not classified · Z-0950-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-0957-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-0965-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-1002-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-0951-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-0966-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-1019-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-1007-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-0947-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-0963-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-0948-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-0998-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-0959-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-1005-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-0942-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-0940-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-0952-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-0941-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-0956-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-0943-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-0954-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-0962-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-1004-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-0946-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-1008-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-0945-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-0961-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-0953-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-0964-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-0939-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-0997-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-0958-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-1001-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-0949-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-1003-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-0960-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-1006-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-0937-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-0968-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-0955-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-0996-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-0999-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-0938-06: Potential for non-sterility due to loss of package integrity - Apr 5, 2006 · Not classified · Z-0944-06: Potential for non-sterility due to loss of package integrity ## Indications for use The Medtronic® Z3 Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Z3 catheter is intended to be used in the coronary or peripheral vascular system. Source page: https://510kreport.com/device/K021256 Methodology: https://510kreport.com/methodology