# K961015: Scimed Choice/Ptca Guide Wire/Plus Ptca Guide Wire/Exchange Ptca Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: Scimed Life Systems, Inc.
- Decided: May 15, 1996 after 63 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
No predicates in its family tree.
30 later devices descend from it; 6 cite it directly.
1 of 31 devices in its family (counting itself) has 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) SCIMED ChoICE™ PTCA Guide Wire: named in the summary without a submission number
- (no number) SCIMED ChoICE™ Plus PTCA Guide Wire: named in the summary without a submission number
- (no number) SCIMED ChoICE™ Exchange PTCA Guide Wire: named in the summary without a submission number

## Most influential descendants
- K962572: Scimed Choice PT Vision Ptca Guide Wire (1996), 16 descendants of its own
- K030617: PT2 Guide Wire and Addwire Extension Wire (2003), 11 descendants of its own
- K970244: Scimed Choice Family of Ptca Guide Wires (1997), 10 descendants of its own
- K021363: Endovascular Guide Wire (2002), 8 descendants of its own
- K143587: ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire (2015), 6 descendants of its own

## Indications for use
The SCIMED ChoICE™ Guide Wires are intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The ChoICE™ Guide Wire family is not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.

Source page: https://510kreport.com/device/K961015
Methodology: https://510kreport.com/methodology