510(k) · Cleared

Cleared

Choice PT Plus Ptca Guide Wire and Choice PT Vision Ptca Guide Wire

K965023510(k) TraditionalCleared Mar 4, 199778-day reviewClass II21 CFR 870.1330

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Scimed Life Systems, Inc. · DQX Wire, Guide, Catheter

Cleared on Mar 4, 1997 as substantially equivalent to K945129 (Scimed Life Systems, Inc., 1995) and 11 other predicates after a 78-day review. Its family tree reaches back 2 generations to 1994. 2 later devices descend from it.

Decided: Mar 4, 1997
Review: 78 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 13

Its longest line of descent runs back 2 generations to K941895 (1994). 16 ancestors in all, the oldest K931514 (1993). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 2 generations backK941895 Scimed 0.014 Ptca Guide Wire with Ice Hydrophilic CoatingScimed Life Systems, Inc. · 1994
1 generation backK962572 Scimed Choice PT Vision Ptca Guide WireScimed Life Systems, Inc. · 1996 · Recalled
This deviceK965023 Choice PT Plus Ptca Guide Wire and Choice PT Vision Ptca Guide WireScimed Life Systems, Inc. · 1997
Descendant · cites it directly · 0 of its ownK974241 Scimed Informer Pressure Wire SystemScimed Life Systems, Inc. · 1998
Descendant · cites it directly · 0 of its ownK980360 Scimed Quest Floppy and Moderate Support Guide WiresScimed Life Systems, Inc. · 1998

Most influential descendants

Showing 2 of 2 · See all

K974241Scimed Informer Pressure Wire SystemScimed Life Systems, Inc. · 1998 · cites it directly0descendants
K980360Scimed Quest Floppy and Moderate Support Guide WiresScimed Life Systems, Inc. · 1998 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K941895	Scimed 0.014 Ptca Guide Wire with Ice Hydrophilic Coating	Scimed Life Systems, Inc.	1994	—
−1	K962572	Scimed Choice PT Vision Ptca Guide Wire	Scimed Life Systems, Inc.	1996	3
0 (this device)	K965023	Choice PT Plus Ptca Guide Wire and Choice PT Vision Ptca Guide Wire	Scimed Life Systems, Inc.	1997	—
+1	K974241	Scimed Informer Pressure Wire System	Scimed Life Systems, Inc.	1998	—
+1	K980360	Scimed Quest Floppy and Moderate Support Guide Wires	Scimed Life Systems, Inc.	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1994	4	0
1995	6	0
1996	3	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	2	0

FIG. 1 — Lineage of K965023, 1994–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DQX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DQX device

#1 K213854 SavvyWirescore 15.7 · 10 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (13)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K945129	Scimed Chioce Plus Ptca Guide Wire Summary page 2 …on on the ChoICE Guide Wires is gg::;:l:i::: substantially equivalent to the proximal section on the following SCIMED products. Product 510(k) Clearance Date CholCE Plus K945129 March 3, 1995 K961015 May 15, 1996 K964551 \| Submitied November 14, 1996 CholCE PT Plus K950216 June 22, 1995 K960657 April 29, 1…	Scimed Life Systems, Inc.	1995	—
*	K961015	Scimed Choice/Ptca Guide Wire/Plus Ptca Guide Wire/Exchange Ptca Guide Wire Summary page 2 …Wires is gg::;:l:i::: substantially equivalent to the proximal section on the following SCIMED products. Product 510(k) Clearance Date CholCE Plus K945129 March 3, 1995 K961015 May 15, 1996 K964551 \| Submitied November 14, 1996 CholCE PT Plus K950216 June 22, 1995 K960657 April 29, 1996 EnTre II1 K942333…	Scimed Life Systems, Inc.	1996	—
Kept off the family tree	K964551	FDA’s K964551 is Choice Super Support Ptca Guide Wire, Choice Plus Super Support Ptca Guide… 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 …: substantially equivalent to the proximal section on the following SCIMED products. Product 510(k) Clearance Date CholCE Plus K945129 March 3, 1995 K961015 May 15, 1996 K964551 \| Submitied November 14, 1996 CholCE PT Plus K950216 June 22, 1995 K960657 April 29, 1996 EnTre II1 K942333 August 31, 1994 (mark…	Scimed Life Systems, Inc.	1997	—
*	K950216	Scimed Choice PT Plus (RM) Ptca Guide Wire Summary page 2 …the following SCIMED products. Product 510(k) Clearance Date CholCE Plus K945129 March 3, 1995 K961015 May 15, 1996 K964551 \| Submitied November 14, 1996 CholCE PT Plus K950216 June 22, 1995 K960657 April 29, 1996 EnTre II1 K942333 August 31, 1994 (marketed as the Sceptor Guide \| K946240 March 31,1995 Wir…	Scimed Life Systems, Inc.	1995	—
*	K960657	Scimed Choice PT Exchange Extra Support Ptca and Long Taper Ptca Guide Wire Summary page 2 …products. Product 510(k) Clearance Date CholCE Plus K945129 March 3, 1995 K961015 May 15, 1996 K964551 \| Submitied November 14, 1996 CholCE PT Plus K950216 June 22, 1995 K960657 April 29, 1996 EnTre II1 K942333 August 31, 1994 (marketed as the Sceptor Guide \| K946240 March 31,1995 Wire) K950534 April 28, 1…	Scimed Life Systems, Inc.	1996	1
*	K942333	Scimed EN Tre' Iii Ptca Guide Wire Summary page 2 …e Date CholCE Plus K945129 March 3, 1995 K961015 May 15, 1996 K964551 \| Submitied November 14, 1996 CholCE PT Plus K950216 June 22, 1995 K960657 April 29, 1996 EnTre II1 K942333 August 31, 1994 (marketed as the Sceptor Guide \| K946240 March 31,1995 Wire) K950534 April 28, 1996 K960563 April 29, 1996 EnTre…	Scimed Life Systems, Inc.	1994	—
*	K946240	Scimed (R) Sceptor (TM) Ptca Guide Wire Summary page 2 …1996 K964551 \| Submitied November 14, 1996 CholCE PT Plus K950216 June 22, 1995 K960657 April 29, 1996 EnTre II1 K942333 August 31, 1994 (marketed as the Sceptor Guide \| K946240 March 31,1995 Wire) K950534 April 28, 1996 K960563 April 29, 1996 EnTre I K931514 June 25, 1993 K935022 January 18, 1993 K935577…	Scimed Life Systems, Inc.	1995	—
*	K950534	Scimed Sceptor Ptca Guide Wire Summary page 2 …ember 14, 1996 CholCE PT Plus K950216 June 22, 1995 K960657 April 29, 1996 EnTre II1 K942333 August 31, 1994 (marketed as the Sceptor Guide \| K946240 March 31,1995 Wire) K950534 April 28, 1996 K960563 April 29, 1996 EnTre I K931514 June 25, 1993 K935022 January 18, 1993 K935577 November 17, 1993 182 cm Cho…	Scimed Life Systems, Inc.	1995	—
*	K960563	Scimed Sceptor & Sceptor Exchange Ptca Guide Wires Summary page 2 …T Plus K950216 June 22, 1995 K960657 April 29, 1996 EnTre II1 K942333 August 31, 1994 (marketed as the Sceptor Guide \| K946240 March 31,1995 Wire) K950534 April 28, 1996 K960563 April 29, 1996 EnTre I K931514 June 25, 1993 K935022 January 18, 1993 K935577 November 17, 1993 182 cm CholCE PT Vision K962572 S…	Scimed Life Systems, Inc.	1996	—
*	K931514	Scimed (R) Entre (TM) II Ptca Guide Wire & Accessory Summary page 2 …60657 April 29, 1996 EnTre II1 K942333 August 31, 1994 (marketed as the Sceptor Guide \| K946240 March 31,1995 Wire) K950534 April 28, 1996 K960563 April 29, 1996 EnTre I K931514 June 25, 1993 K935022 January 18, 1993 K935577 November 17, 1993 182 cm CholCE PT Vision K962572 Submitted July 1, 1996. Proximal…	Scimed Life Systems, Inc.	1993	—
*	K935022	Scimed Entre II Ptca Guide Wire Modification Summary page 2 …nTre II1 K942333 August 31, 1994 (marketed as the Sceptor Guide \| K946240 March 31,1995 Wire) K950534 April 28, 1996 K960563 April 29, 1996 EnTre I K931514 June 25, 1993 K935022 January 18, 1993 K935577 November 17, 1993 182 cm CholCE PT Vision K962572 Submitted July 1, 1996. Proximal The proximal section…	Scimed Life Systems, Inc.	1994	—
*	K935577	Scimed Entre II Ptca Guide Wire Summary page 2 …1, 1994 (marketed as the Sceptor Guide \| K946240 March 31,1995 Wire) K950534 April 28, 1996 K960563 April 29, 1996 EnTre I K931514 June 25, 1993 K935022 January 18, 1993 K935577 November 17, 1993 182 cm CholCE PT Vision K962572 Submitted July 1, 1996. Proximal The proximal section of the guide wire consist…	Scimed Life Systems, Inc.	1994	—
*	K962572	Scimed Choice PT Vision Ptca Guide Wire Cleared while this submission was under review Summary page 2 …arch 31,1995 Wire) K950534 April 28, 1996 K960563 April 29, 1996 EnTre I K931514 June 25, 1993 K935022 January 18, 1993 K935577 November 17, 1993 182 cm CholCE PT Vision K962572 Submitted July 1, 1996. Proximal The proximal section of the guide wire consists of a differential IS)?;tcll(')il:) tion magnetic…	Scimed Life Systems, Inc.	1996	3

Also cleared against K945129: 5 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K974241	Scimed Informer Pressure Wire System	Scimed Life Systems, Inc.	1998	0
K980360	Scimed Quest Floppy and Moderate Support Guide Wires	Scimed Life Systems, Inc.	1998	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 2.6 years on median.
2 of the 16 ancestors have a recall of any class.
Of its descendants, K974241 (Scimed Life Systems, Inc., 1998) has gone furthest, with 0 descendants of its own.
5 other devices also cite its predicate K945129.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQX

10in 2025

2007high 21 (2010) · low 6 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQX

177in 2025

2007high 212 (2022) · low 43 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQX

3in 2024

2007high 49 (2009) · low 0 (2014)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · DQX

2,178in 2025

2007high 2,210 (2024) · low 687 (2009)2025

MAUDE reports naming product code DQX, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	14	85	12	760
2008	19	87	7	715
2009	18	87	49	687
2010	21	63	34	987
2011	18	43	3	1,311
2012	20	62	5	1,337
2013	18	119	7 (4)	1,474
2014	18	103	0	1,323
2015	15	112	1	1,323
2016	14	179	2 (2)	1,466
2017	19	85	17	1,524
2018	19	114	9	1,737
2019	13	173	2	1,679
2020	14	106	1 (1)	1,536
2021	6	161	0	1,713
2022	15	212	0	1,647
2023	10	136	0	2,068
2024	11	134	3	2,210
2025	10	177	0	2,178
2026	12	145	4 (1)	—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K965023 · printed Nov 4, 2026

Cite this page

510(k) Report. “K965023: Choice PT Plus Ptca Guide Wire and Choice PT Vision Ptca Guide Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K965023

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026