# K070212: CITOP10 Guidewire, 0.014(1.4MM Tip), CITOP6 Guidewire, 0.014(1.0MM Tip), Citop Support Accessory, 0.023(126CM)

- Pathway: 510(k) (Traditional)
- Applicant: Ovalum, Ltd.
- Decided: Oct 12, 2007 after 263 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: 6 generations back to K890505 (1989). 23 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041531: Asahi Ptca Guide Wire Confianza Pro, Asahi Intecc Co., Ltd. (2004) Summary page 1.
- K040592: Cordis Steer-IT Deflecting Tip Guidewire, Cordis Corp. (2004) Summary page 1.
- K013284: Lumend Frontrunner Cto Coronary Catheter, Lumend, Inc. (2002) Summary page 1.

## Most influential descendants
- K171897: Approach CTO Microwire Guide (2017), 0 descendants of its own

## Indications for use
The CiTopTM Guidewire is intended for use in angiographic procedures to facilitate the intra-luminal placement of the wire beyond stenotic lesibns (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention.

Source page: https://510kreport.com/device/K070212
Methodology: https://510kreport.com/methodology