# K962572: Scimed Choice PT Vision Ptca Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: Scimed Life Systems, Inc.
- Decided: Dec 17, 1996 after 169 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K941895 (1994). 9 ancestors in all.
16 later devices descend from it; 3 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943192: Scimed Choice (TM) Ptca Guide Wire, Scimed Life Systems, Inc. (1994) Summary page 1.
- K961015: Scimed Choice/Ptca Guide Wire/Plus Ptca Guide Wire/Exchange Ptca Guide Wire, Scimed Life Systems, Inc. (1996) Summary page 1.
- K945129: Scimed Chioce Plus Ptca Guide Wire, Scimed Life Systems, Inc. (1995) Summary page 1.
- K950113: Scimed (R) Chice (TM) Exchange Ptca Guide Wire, Scimed Life Systems, Inc. (1995) Summary page 1.
- K941895: Scimed 0.014 Ptca Guide Wire with Ice Hydrophilic Coating, Scimed Life Systems, Inc. (1994) Summary page 1.
- K960657: Scimed Choice PT Exchange Extra Support Ptca and Long Taper Ptca Guide Wire, Scimed Life Systems, Inc. (1996) Summary page 1.
- K950216: Scimed Choice PT Plus (RM) Ptca Guide Wire, Scimed Life Systems, Inc. (1995) Summary page 1.
- K950266: Scimed (R) Choice (TM) PT Exchange Ptca Guide Wire, Scimed Life Systems, Inc. (1995) Summary page 1.
- K960563: Scimed Sceptor & Sceptor Exchange Ptca Guide Wires, Scimed Life Systems, Inc. (1996) Summary page 1.

## Most influential descendants
- K030617: PT2 Guide Wire and Addwire Extension Wire (2003), 11 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
- K032183: IQ Hydrophilic Guide Wire (2003), 4 descendants of its own
- K040140: IQ Guide Wire (2004), 3 descendants of its own
- K152231: Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire (2016), 2 descendants of its own

## Recalls of this device
- Nov 19, 2002 · Not classified · Z-0592-03: Product is mislabled as a ChoICE Floppy Guide Wire when it is actually a ChoICE ES(Extra Support) Guide Wire.
- Aug 22, 2002 · Not classified · Z-0591-03: Product labeled as Scimed ChoICE PT Extra Suport PTCA Guide Wire 300 cm were actually Scimed PT Graphix Intermediate PTCA Guide Wire 300 cm
- Jul 16, 2002 · Not classified · Z-0589-03: Labeled as J tip but may be straight tip.

## Indications for use
The SCIMED CholCE PT Vision PTCA 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 PT Vision 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/K962572
Methodology: https://510kreport.com/methodology