# K981198: Medtronic Zuma Guiding Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medtronics Interventional Vascular
- Decided: Aug 7, 1998 after 127 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 25 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
29 later devices descend from it; 2 cite it directly.
3 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Medtronic® Vector™ X Guiding Catheter: named in the summary without a submission number
- (no number) Cordis® Brite Tip® Guiding Catheter: named in the summary without a submission number

## Most influential descendants
- K021256: Z3 Guide Catheter (2002), 24 descendants of its own
- K022764: 7F Launcher Guide Catheter (2002), 11 descendants of its own
- K030779: 5F Medtronic Launcher Guide Catheter (2003), 10 descendants of its own
- K042489: 6F Z4 Guide Catheter (2004), 8 descendants of its own
- K023402: 8F Launcher Guide Catheter (2002), 8 descendants of its own

## Recalls of this device
- Apr 5, 2006 · Not classified · Z-1010-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1012-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1013-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1059-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1061-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1062-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1063-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1064-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1065-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1066-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1072-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1011-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1058-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1071-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1060-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1067-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1069-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1068-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1070-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1074-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1073-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1076-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1075-06: Potential for non-sterility due to loss of package integrity
- Mar 17, 2003 · Not classified · Z-0799-03: The PTCA catheter is mislabeled: the curve style (Judkin Left vs. Judkin Right ) of the catheter may not correctly match the box label.
- Mar 17, 2003 · Not classified · Z-0800-03: The PTCA catheter is mislabeled: the curve style (Judkin Left vs. Judkin Right ) of the catheter may not correctly match the box label.

## Indications for use
The Medtronic® Zuma™ Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Zuma catheter is intended to be used in the coronary or peripheral vascular system.

Source page: https://510kreport.com/device/K981198
Methodology: https://510kreport.com/methodology