# K965023: Choice PT Plus Ptca Guide Wire and Choice PT Vision Ptca Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: Scimed Life Systems, Inc.
- Decided: Mar 4, 1997 after 78 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: 2 generations back to K941895 (1994). 16 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945129: Scimed Chioce Plus Ptca Guide Wire, Scimed Life Systems, Inc. (1995) Summary page 2.
- K961015: Scimed Choice/Ptca Guide Wire/Plus Ptca Guide Wire/Exchange Ptca Guide Wire, Scimed Life Systems, Inc. (1996) Summary page 2.
- K950216: Scimed Choice PT Plus (RM) Ptca Guide Wire, Scimed Life Systems, Inc. (1995) Summary page 2.
- K960657: Scimed Choice PT Exchange Extra Support Ptca and Long Taper Ptca Guide Wire, Scimed Life Systems, Inc. (1996) Summary page 2.
- K942333: Scimed EN Tre' Iii Ptca Guide Wire, Scimed Life Systems, Inc. (1994) Summary page 2.
- K946240: Scimed (R) Sceptor (TM) Ptca Guide Wire, Scimed Life Systems, Inc. (1995) Summary page 2.
- K950534: Scimed Sceptor Ptca Guide Wire, Scimed Life Systems, Inc. (1995) Summary page 2.
- K960563: Scimed Sceptor & Sceptor Exchange Ptca Guide Wires, Scimed Life Systems, Inc. (1996) Summary page 2.
- K931514: Scimed (R) Entre (TM) II Ptca Guide Wire & Accessory, Scimed Life Systems, Inc. (1993) Summary page 2.
- K935022: Scimed Entre II Ptca Guide Wire Modification, Scimed Life Systems, Inc. (1994) Summary page 2.
- K935577: Scimed Entre II Ptca Guide Wire, Scimed Life Systems, Inc. (1994) Summary page 2.
- K962572: Scimed Choice PT Vision Ptca Guide Wire, Scimed Life Systems, Inc. (1996). Cleared while this submission was under review Summary page 2.

## Cited in the summary but kept off the family tree
- K964551: Choice Super Support Ptca Guide Wire, Choice Plus Super Support Ptca Guide Wire, Choice Exchange Super Support Ptca Guid, Scimed Life Systems, Inc. (1997). Our OCR of the scanned summary read K964551, which FDA decided on May 21, 1997, after this device was decided (Mar 4, 1997), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree. Summary page 2.

## Most influential descendants
- K974241: Scimed Informer Pressure Wire System (1998), 0 descendants of its own
- K980360: Scimed Quest Floppy and Moderate Support Guide Wires (1998), 0 descendants of its own

## Indications for use
The SCIMED CholCE Plus, ChoICE PT Plus and the 182 cm CholCE PT Vision 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 CholCE Plus, CholCE PT Plus and the 182 cm CholICE PT Vision 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/K965023
Methodology: https://510kreport.com/methodology