# K010579: Stent Support Guide Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Nov 21, 2001 after 267 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 27 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
86 later devices descend from it; 3 cite it directly.
5 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K030201: Modification to Export Aspiration Catheter (2003), 60 descendants of its own
- K040869: Export Catheter (2004), 59 descendants of its own
- K061958: Medtronic Export XT Catheter (2006), 30 descendants of its own
- K021256: Z3 Guide Catheter (2002), 24 descendants of its own
- K050130: Kerberos Proximal Solutions Rispiration System (2005), 16 descendants of its own

## Recalls of this device
- Jun 8, 2011 · Not classified · Z-2754-2011: Mislabeled; Product labeled as 6F Zuma Guide with AL 1.5 curve with side holes may contain a 5F Zuma Catheter with SAL 1.0 curve
- Apr 5, 2006 · Not classified · Z-1014-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1015-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1016-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1026-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1027-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1028-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1029-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1030-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1031-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1036-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1037-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1023-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1024-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1035-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1017-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1021-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1025-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1038-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1039-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1018-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1020-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1022-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1032-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1033-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1034-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1040-06: Potential for non-sterility due to loss of package integrity

Source page: https://510kreport.com/device/K010579
Methodology: https://510kreport.com/methodology