# K961280: Scimed 6-10 F Triguide Guide Catheters 6F,7F,8F,9F & 10F

- Pathway: 510(k) (Traditional)
- Applicant: Scimed Life Systems, Inc.
- Decided: May 15, 1996 after 42 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- 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® 6,7,8,9 and 10 French TRIGUIDE® Guide Catheters: named in the summary without a submission number
- (no number) Cordis® Corporation Vista Brite Tip™ Guide Catheter: 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
The SCIMED guide catheters are designed to provide a pathway through which medical instruments, such as balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature.

Source page: https://510kreport.com/device/K961280
Methodology: https://510kreport.com/methodology