# K970528: Clyde Coronary Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Schneider (Europe) GmbH
- Decided: Jun 10, 1997 after 119 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
73 later devices descend from it; 1 cites it directly.
0 of 74 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) C-Thru Coronary Guidewire: named in the summary without a submission number

## Most influential descendants
- K013284: Lumend Frontrunner Cto Coronary Catheter (2002), 72 descendants of its own
- K023114: Lumend Frontrunner Cto Catheter (2003), 69 descendants of its own
- K040067: Clirpath Excimer Laser Catheter (2004), 36 descendants of its own
- K031005: Lumend Frontrunner GW Cto Catheter (2003), 32 descendants of its own
- K033535: Lumend Frontrunner Cto Catheter and Accessories (2004), 31 descendants of its own

## Indications for use
The Clyde Coronary Guidewire is intended for use in percutaneous procedures to reach and cross stenotic lesions prior to the insertion of a coronary balloon dilation catheter.

Source page: https://510kreport.com/device/K970528
Methodology: https://510kreport.com/methodology