# K031505: Rapido Cut-Away Guiding Catheter

- Pathway: 510(k) (Special)
- Applicant: Guidant Corporation
- Decided: Jun 25, 2003 after 42 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: 3 generations back to K953987 (1995). 4 ancestors in all.
21 later devices descend from it; 3 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021455: Rapido Guiding Catheter, 6F Model# 6776; Rapido Guiding Catheter, 8F Model# 6775, 6777, 6778, 6779, 6780, 6781, 6782,, Guidant Corp. (2002)

## Most influential descendants
- 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
- K101885: Medtronic C315 Delivery Catheter (2010), 8 descendants of its own
- K190475: Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4 (2019), 5 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

## Indications for use
The Guidant RAPIDO Cut-Away 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/K031505
Methodology: https://510kreport.com/methodology