# K042194: Attain Select 6238TEL Guide Catheter Set for Left-Heart Delivery

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Sep 15, 2004 after 34 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K893658 (1989). 46 ancestors in all.
17 later devices descend from it; 3 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021589: Attain Access 6218A Left-Heart Delivery System, Model 6218, Medtronic Vascular (2002) Summary page 2.
- K031211: Attain Prevail Steerable Catheter Set, Model 6228CTH, Medtronic Vascular (2003) Summary page 2.
- K021455: Rapido Guiding Catheter, 6F Model# 6776; Rapido Guiding Catheter, 8F Model# 6775, 6777, 6778, 6779, 6780, 6781, 6782,, Guidant Corp. (2002) Summary page 2.

## 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

## Indications for use
The Attain SelectTM 6238TEL Guide Catheter Set for Left-Heart Delivery is intended for the delivery of contrast media and transvenous devices to the coronary sinus and left heart venotomy. The 6238TEL guide catheters are indicated for use with an outer guide catheter delivery system, forming a dual-catheter assembly.

Source page: https://510kreport.com/device/K042194
Methodology: https://510kreport.com/methodology