# K961271: Usci Commander Series Guide Wires

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Jun 27, 1996 after 86 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 K890505 (1989). 1 ancestor in all.
191 later devices descend from it; 2 cite it directly.
3 of 193 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K890505: Usci Grey/Black Guide Wire, C.R. Bard, Inc. (1989) Summary page 2.

## Most influential descendants
- K990639: Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat Hydrophilic Coating. (1999), 189 descendants of its own
- K022762: Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050 (2002), 104 descendants of its own
- K031277: Jowire Asahi Ptca Catheter Guide Wires, Models AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002 (2003), 92 descendants of its own
- K041531: Asahi Ptca Guide Wire Confianza Pro (2004), 79 descendants of its own
- K011986: Safe-Steer Guide Wire System (2002), 76 descendants of its own

## Indications for use
The Commander Series Guide Wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. The Commander Series guide wires are not intended for use in the cerebral vasculature, Commander steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.

Source page: https://510kreport.com/device/K961271
Methodology: https://510kreport.com/methodology