# K013517: 10600 Deflectable Catheter System, Model 10600

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Apr 25, 2002 after 185 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: 3 generations back to K893658 (1989). 34 ancestors in all.
80 later devices descend from it; 4 cite it directly.
5 of 115 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012130: Attain LDS 6216 Left-Heart Delivery System, Medtronic Vascular (2001) Summary page 2.
- K012083: Attain Access 6218 Left-Heart Delivery System, Model 6218, Medtronic Vascular (2001) Summary page 2.
- K950179: Medtronic (R) GC Iii Coronary Guiding Catheter, Medtronics Interventional Vascular (1995) Summary page 2.
- K974683: Naviport Deflectable Tip Guiding Catheter, Cardima, Inc. (1999) Summary page 2.
- K003731: Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve, Thomas Medical Products, Inc. (2001) Summary page 2.
- K931794: Marinr Series EP Diagnostic Catheters, Medtronic Cardiorhythm (1994) Summary page 2.

## Most influential descendants
- K032312: Attain 6226DEF Deflectable Catheter Delivery System (2003), 37 descendants of its own
- K033989: Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69 (2004), 35 descendants of its own
- K072313: Amplatzer Torqvue Delivery System (2007), 30 descendants of its own
- K031211: Attain Prevail Steerable Catheter Set, Model 6228CTH (2003), 29 descendants of its own
- K042194: Attain Select 6238TEL Guide Catheter Set for Left-Heart Delivery (2004), 17 descendants of its own

## Indications for use
The deflectable catheter system is indicated to provide a pathway through which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart, and for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.

Source page: https://510kreport.com/device/K013517
Methodology: https://510kreport.com/methodology