# K923607: Radifocus Guide Wire M

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: Oct 2, 1992 after 78 days
- Product code: KOD (Catheter, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K131072: Orchestra Hydrophilic Guidewire Standard Angled, Orchestra Hydrophilic Guidewire Straight Stiff, Orchestra Hydrophilic (2013), 1 descendant of its own
- K150927: Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff (2015), 0 descendants of its own
- K060034: Nipro Hydrophilic Guidewire for Urological & Laparoscopic Use (2006), 0 descendants of its own

Source page: https://510kreport.com/device/K923607
Methodology: https://510kreport.com/methodology