# K982883: Medtronic 7F and 8F Zuma Guiding Catheter

- Pathway: 510(k) (Special)
- Applicant: Medtronics Interventional Vascular
- Decided: Sep 4, 1998 after 18 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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® Vector™ 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

## Recalls of this device
- Apr 5, 2006 · Not classified · Z-1047-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1050-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1053-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1052-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1044-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1051-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1045-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1046-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1048-06: Potential for non-sterility due to loss of package integrity
- Apr 5, 2006 · Not classified · Z-1049-06: 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/K982883
Methodology: https://510kreport.com/methodology