# K031211: Attain Prevail Steerable Catheter Set, Model 6228CTH

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Jul 17, 2003 after 91 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: 4 generations back to K893658 (1989). 41 ancestors in all.
29 later devices descend from it; 4 cite it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013517: 10600 Deflectable Catheter System, Model 10600, Medtronic Vascular (2002)
- K021587: Attain LDS 6216A Left-Heart Delivery System, Model 6216A, Medtronic Vascular (2002)
- K021589: Attain Access 6218A Left-Heart Delivery System, Model 6218, Medtronic Vascular (2002)
- K931794: Marinr Series EP Diagnostic Catheters, Medtronic Cardiorhythm (1994) Summary page 2.
- K974683: Naviport Deflectable Tip Guiding Catheter, Cardima, Inc. (1999) Summary page 2.
- P790017: Usci Dilatation Catheter, Medtronic, Ireland (1980) Summary page 2.
- K945461: Piton (TM) Y-Pack and Piton (TM) Tri-Pack), Medtronics Interventional Vascular (1995) Summary page 2.
- K895580: Y-Adapter W/Thouy Borst, Angeion Corp. (1990)
- K760385: Extension Sets, B. Braun Instruments (1976) Summary page 2.
- K921702: Meri-Dapt (TM) Hemostasis Valve/Torqloc Torque Devi, Merit Medical Systems, Inc. (1992)
- (no number) Medex Stopcock and Luer Lock Plug Model MX531-1L: named in the summary without a submission number
- (no number) Guide Wire Clip: named in the summary without a submission number

## Most influential descendants
- 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
- K101885: Medtronic C315 Delivery Catheter (2010), 8 descendants of its own

## Indications for use
The Attain Prevail Steerable Catheter Set is indicated to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.

Source page: https://510kreport.com/device/K031211
Methodology: https://510kreport.com/methodology