# K970466: Radius Ptca Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Radius Medical Technologies, Inc.
- Decided: May 20, 1997 after 102 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
49 later devices descend from it; 5 cite it directly.
8 of 50 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) ACS High Torque Guidewire family: named in the summary without a submission number

## Most influential descendants
- K021441: Radius Snare (2002), 36 descendants of its own
- K022201: Radius Micro Snare (2003), 32 descendants of its own
- K032426: Gunhter Tulip Vena Cava Mreye Filter and Retrieval Set (2003), 31 descendants of its own
- K073374: Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval Set (2008), 16 descendants of its own
- K091582: GTX Guidewire, Models TBD-GTX 1, 3,6,9,12, 15 (2009), 10 descendants of its own

## Recalls of this device
- Oct 21, 2013 · Class I · Z-0267-2014: Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.
- Oct 21, 2013 · Class I · Z-0263-2014: Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.

## Indications for use
The Radius PTCA Guidewire is indicated to facilitate the placement of balloon dilatation catheters during PTCA and/or PTA.

Source page: https://510kreport.com/device/K970466
Methodology: https://510kreport.com/methodology