# K021284: Easytrak Guiding Catheter - Pathway: 510(k) (Traditional) - Applicant: Guidant Corp. - Decided: May 2, 2002 after 14 days - Product code: DQY (Catheter, Percutaneous) - Device class: 2 - Regulation: 21 CFR 870.1250 - Recalls of this device: 17 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 1 generation back to K953987 (1995). 2 ancestors in all. 26 later devices descend from it; 1 cites it directly. 0 of 29 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K973298: Cardima Vueport Coronary Sinus Balloon Occlusion Guiding Catheter, Cardima, Inc. (1998) Summary page 1. - K953987: Acs Tourgide Guiding Catheter, Advanced Cardiovascular Systems, Inc. (1995) Summary page 1. ## Most influential descendants - K021455: Rapido Guiding Catheter, 6F Model# 6776; Rapido Guiding Catheter, 8F Model# 6775, 6777, 6778, 6779, 6780, 6781, 6782, (2002), 25 descendants of its own - K031505: Rapido Cut-Away Guiding Catheter (2003), 21 descendants of its own - K042194: Attain Select 6238TEL Guide Catheter Set for Left-Heart Delivery (2004), 17 descendants of its own - K053431: Attain Select II 6248DEL Delivery Catheter System (2006), 14 descendants of its own - K080428: Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide Catheters for Left Heart Delivery (2008), 13 descendants of its own ## Recalls of this device - Mar 11, 2004 · Not classified · Z-0801-04: The terminal hub component in a some of the catheters has an unintended abrupt transition between the entry port and the catheter lumen which can result in difficulty introducing or removing delivery - Mar 11, 2004 · Not classified · Z-0806-04: The terminal hub component in a some of the catheters has an unintended abrupt transition between the entry port and the catheter lumen which can result in difficulty introducing or removing delivery - Mar 11, 2004 · Not classified · Z-0795-04: The terminal hub component in a some of the catheters has an unintended abrupt transition between the entry port and the catheter lumen which can result in difficulty introducing or removing delivery - Mar 11, 2004 · Not classified · Z-0805-04: The terminal hub component in a some of the catheters has an unintended abrupt transition between the entry port and the catheter lumen which can result in difficulty introducing or removing delivery - Mar 11, 2004 · Not classified · Z-0790-04: The terminal hub component in a some of the catheters has an unintended abrupt transition between the entry port and the catheter lumen which can result in difficulty introducing or removing delivery - Mar 11, 2004 · Not classified · Z-0794-04: The terminal hub component in a some of the catheters has an unintended abrupt transition between the entry port and the catheter lumen which can result in difficulty introducing or removing delivery - Mar 11, 2004 · Not classified · Z-0798-04: The terminal hub component in a some of the catheters has an unintended abrupt transition between the entry port and the catheter lumen which can result in difficulty introducing or removing delivery - Mar 11, 2004 · Not classified · Z-0800-04: The terminal hub component in a some of the catheters has an unintended abrupt transition between the entry port and the catheter lumen which can result in difficulty introducing or removing delivery - Mar 11, 2004 · Not classified · Z-0802-04: The terminal hub component in a some of the catheters has an unintended abrupt transition between the entry port and the catheter lumen which can result in difficulty introducing or removing delivery - Mar 11, 2004 · Not classified · Z-0791-04: The terminal hub component in a some of the catheters has an unintended abrupt transition between the entry port and the catheter lumen which can result in difficulty introducing or removing delivery - Mar 11, 2004 · Not classified · Z-0792-04: The terminal hub component in a some of the catheters has an unintended abrupt transition between the entry port and the catheter lumen which can result in difficulty introducing or removing delivery - Mar 11, 2004 · Not classified · Z-0793-04: The terminal hub component in a some of the catheters has an unintended abrupt transition between the entry port and the catheter lumen which can result in difficulty introducing or removing delivery - Mar 11, 2004 · Not classified · Z-0796-04: The terminal hub component in a some of the catheters has an unintended abrupt transition between the entry port and the catheter lumen which can result in difficulty introducing or removing delivery - Mar 11, 2004 · Not classified · Z-0797-04: The terminal hub component in a some of the catheters has an unintended abrupt transition between the entry port and the catheter lumen which can result in difficulty introducing or removing delivery - Mar 11, 2004 · Not classified · Z-0799-04: The terminal hub component in a some of the catheters has an unintended abrupt transition between the entry port and the catheter lumen which can result in difficulty introducing or removing delivery - Mar 11, 2004 · Not classified · Z-0803-04: The terminal hub component in a some of the catheters has an unintended abrupt transition between the entry port and the catheter lumen which can result in difficulty introducing or removing delivery - Mar 11, 2004 · Not classified · Z-0804-04: The terminal hub component in a some of the catheters has an unintended abrupt transition between the entry port and the catheter lumen which can result in difficulty introducing or removing delivery ## Indications for use The Guidant EASYTRAK Guiding Catheter is intended to access the coronary sinus. The catheter serves as a conduit for the delivery and support of devices introduced into the coronary venous system. Source page: https://510kreport.com/device/K021284 Methodology: https://510kreport.com/methodology