# K101729: Neowire Pta/Ptca Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Neometrics, Inc.
- Decided: Sep 23, 2010 after 94 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: 8 generations back to K890505 (1989). 28 ancestors in all.
No later device cites it as a predicate yet.
1 of 29 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070150: Vascupuncture Picc Guidewire, Neometrics, Inc. (2007) Summary page 1.
- K983927: GT1 Floppy, GT1 HI-Per Flex, GT1 Light Support, Arterial Vascular Engineering, Inc. (1999) Summary page 1.
- K013024: Selectiva Guidewire, Neometrics, Inc. (2001) Summary page 1.
- K082304: Roll-X Guidewire, St Jude Medical (2008) Summary page 1.
- K081337: Approach Cto Wire Guide, Cook Incorporated (2008) Summary page 1.

## Indications for use
The N~eoWire Guidewire is Intended to facilitate the Introduction and placement of catheters and interventional devices within the coronary and/or peripheral vasculature. Models with stiff tips I(> 9g) are intended for peripheral use only. Models with Floppy, Soft, and Medium tips (5 9g) are Intended for peripheral or coronary use. The guidewire Isnot Intended for use Inthe cerebral vasculature.

Source page: https://510kreport.com/device/K101729
Methodology: https://510kreport.com/methodology