# K021455: Rapido Guiding Catheter, 6F Model# 6776; Rapido Guiding Catheter, 8F Model# 6775, 6777, 6778, 6779, 6780, 6781, 6782,

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Corp.
- Decided: Aug 2, 2002 after 88 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: 2 generations back to K953987 (1995). 3 ancestors in all.
25 later devices descend from it; 4 cite 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)
- K021284: Easytrak Guiding Catheter, Guidant Corp. (2002) Summary page 1.

## Most influential descendants
- 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
- K090659: Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left Heart Delivery (2009), 12 descendants of its own

## Recalls of this device
- Jan 7, 2011 · Not classified · Z-2793-2011: Five lots of Guide Catheters and Accessory products were processed through Ethylene Oxide (ETO) sterilization with additional plastic material covering the pallet, which is not consistent with validat
- 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 Guiding Catheter is intended to access the coronary venous system, and may be used as a dual-catheter assembly. The catheter serves as a conduit for the delivery of contrast medium and devices, including implantable coronary venous leads, introduced into the coronary venous system.

Source page: https://510kreport.com/device/K021455
Methodology: https://510kreport.com/methodology