# K960657: Scimed Choice PT Exchange Extra Support Ptca and Long Taper Ptca Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: Scimed Life Systems, Inc.
- Decided: Apr 29, 1996 after 73 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
27 later devices descend from it; 3 cite it directly.
1 of 28 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 PT PTCA Guide Wire: named in the summary without a submission number
- (no number) SCIMED ChoICE PT Plus PTCA Guide Wire: named in the summary without a submission number
- (no number) SCIMED ChoICE PT 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

## Recalls of this device
- Aug 22, 2002 · Not classified · Z-0590-03: Product labeled as Scimed ChoICE PT Extra Suport PTCA Guide Wire 300 cm were actually Scimed PT Graphix Intermediate PTCA Guide Wire 300 cm

## Indications for use
The SCIMED CholCE PT, ChoICE PT Plus and CholICE PT Exchange Extra Support and Extra Support Long Taper PTCA Guide Wires are intended to facilitate the placement asé exshamge of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The ChoICE PT, ChoICE PT Plus and ChoICE PT Exchange Extra Support and Extra Support Long Taper PTCA Guide Wires are 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/K960657
Methodology: https://510kreport.com/methodology