# K990707: Medtronic 5F & 9F Zuma Guiding Catheters

- Pathway: 510(k) (Special)
- Applicant: Medtronics Interventional Vascular
- Decided: Mar 22, 1999 after 18 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
100 later devices descend from it; 2 cite it directly.
5 of 101 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® 6F Zuma™ Guiding Catheter: named in the summary without a submission number
- (no number) Medtronic® 7F, 8F Zuma™ Guiding Catheter: named in the summary without a submission 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
- K012130: Attain LDS 6216 Left-Heart Delivery System (2001), 97 descendants of its own
- K012083: Attain Access 6218 Left-Heart Delivery System, Model 6218 (2001), 89 descendants of its own
- K013517: 10600 Deflectable Catheter System, Model 10600 (2002), 80 descendants of its own
- 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

## 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-1055-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1056-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1057-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1054-06: Potential for non-sterility due to loss of package integrity

## 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/K990707
Methodology: https://510kreport.com/methodology