# K971034: Usci Mainstay Guiding Catheter

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: May 28, 1997 after 68 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
38 later devices descend from it; 2 cite it directly.
3 of 39 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) Scimed Guiding Catheters: named in the summary without a submission number
- (no number) USCI Guiding Catheters: named in the summary without a submission number

## Most influential descendants
- K012749: Biocardia Universal Deflectable Guide Catheter, Model 000664 (2002), 37 descendants of its own
- K040922: Venture Wire Control Catheter (2004), 31 descendants of its own
- K042910: Venture Wire Control Catheter, Model WCC (2004), 30 descendants of its own
- K061843: Venture Wire Control Catheter, Model WCC (2006), 28 descendants of its own
- K080987: Bridgepoint Medical Stingray Device and Accessories (2009), 24 descendants of its own

## Indications for use
USCI® guiding catheters are designed for use in the cardiovascular system. Their primary function is to provide a pathway through which dilatation systems and other interventional devices are introduced. Guiding catheters also allow pressure monitoring and injection of contrast agents.

Source page: https://510kreport.com/device/K971034
Methodology: https://510kreport.com/methodology