# K961445: Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: Jul 9, 1996 after 84 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
Longest line of descent: 1 generation back to K953533 (1995). 1 ancestor in all.
51 later devices descend from it; 3 cite it directly.
5 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953533: Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil, Terumo Medical Corp. (1995) Summary page 1.

## Most influential descendants
- K063695: Runthrough NS (2007), 31 descendants of its own
- K980385: Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional Sheathless Insertion with Accessories (1998), 17 descendants of its own
- K994157: Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models 0684-00-0327, 06844-00-0328, 0684-00-0329 (2000), 15 descendants of its own
- K013326: Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC, Datascope Insertion Kit for 8 FR, Polyimide Alt B (2001), 14 descendants of its own
- K103101: HI-Torque Balance Middleweight Elite (2011), 13 descendants of its own

## Indications for use
The RADIFOCUS Glidewires for coronary use with platinum (or gold) coil are used to facilitate the placement of ballon dilatation catheters for percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).

Source page: https://510kreport.com/device/K961445
Methodology: https://510kreport.com/methodology