510(k) · Cleared

Cleared

Choice Super Support Ptca Guide Wire, Choice Plus Super Support Ptca Guide Wire, Choice Exchange Super Support Ptca Guid

K964551510(k) TraditionalCleared May 21, 1997189-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 May 21, 1997 as substantially equivalent to K943192 (Scimed Life Systems, Inc., 1994) and 4 other predicates after a 189-day review. Its family tree reaches back 1 generation to 1994. 4 later devices descend from it.

Decided: May 21, 1997
Review: 189 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 5

Its longest line of descent runs back 1 generation to K943192 (1994). 5 ancestors in all. 4 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK943192 Scimed Choice (TM) Ptca Guide WireScimed Life Systems, Inc. · 1994
This deviceK964551 Choice Super Support Ptca Guide Wire, Choice Plus Super Support Ptca…Scimed Life Systems, Inc. · 1997
Descendant · cites it directly · 1 of its ownK090554 Acuity Mailman and Strait-Trak GuidewireBoston Scientific Corp · 2009
Descendant · 2 generations on · 0 of its ownK110479 Acuity Whisper View Guide WiresBoston Scientific Corp · 2011
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 4 of 4 · See all

K090554Acuity Mailman and Strait-Trak GuidewireBoston Scientific Corp · 2009 · cites it directly1descendant
K110479Acuity Whisper View Guide WiresBoston Scientific Corp · 2011 · 2 generations on0descendants
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
−1	K943192	Scimed Choice (TM) Ptca Guide Wire	Scimed Life Systems, Inc.	1994	—
0 (this device)	K964551	Choice Super Support Ptca Guide Wire, Choice Plus Super Support Ptca Guide…	Scimed Life Systems, Inc.	1997	—
+1	K090554	Acuity Mailman and Strait-Trak Guidewire	Boston Scientific Corp	2009	—
+2	K110479	Acuity Whisper View Guide Wires	Boston Scientific Corp	2011	—
+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
1995	3	0
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	2	0
2009	1	0
2011	1	0

FIG. 1 — Lineage of K964551, 1994–2011Source: 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? (5)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K943192	Scimed Choice (TM) Ptca Guide Wire Summary page 2 …e ChoICE Super Support and Super Support IT Guide Wire models Devices are substantially equivalent to the following SCIMED products. Product 510(k) Clearance Date ChoICE K943192 November 22, 1994 K950141 March 3, 1995 K961015 May 15, 1996 CholCE Plus K945129 March 3, 1995 K961015 May 15, 1996 ChoICE Exchan…	Scimed Life Systems, Inc.	1994	—
*	K950141	Scimed (R) Choice (TM) Ptca Guide Wire Summary page 2 …Super Support IT Guide Wire models Devices are substantially equivalent to the following SCIMED products. Product 510(k) Clearance Date ChoICE K943192 November 22, 1994 K950141 March 3, 1995 K961015 May 15, 1996 CholCE Plus K945129 March 3, 1995 K961015 May 15, 1996 ChoICE Exchange K950113 March 31, 1995…	Scimed Life Systems, Inc.	1995	—
*	K961015	Scimed Choice/Ptca Guide Wire/Plus Ptca Guide Wire/Exchange Ptca Guide Wire Summary page 2 …e Wire models Devices are substantially equivalent to the following SCIMED products. Product 510(k) Clearance Date ChoICE K943192 November 22, 1994 K950141 March 3, 1995 K961015 May 15, 1996 CholCE Plus K945129 March 3, 1995 K961015 May 15, 1996 ChoICE Exchange K950113 March 31, 1995 K961015 May 15, 1996 C…	Scimed Life Systems, Inc.	1996	—
*	K945129	Scimed Chioce Plus Ptca Guide Wire Summary page 2 …tially equivalent to the following SCIMED products. Product 510(k) Clearance Date ChoICE K943192 November 22, 1994 K950141 March 3, 1995 K961015 May 15, 1996 CholCE Plus K945129 March 3, 1995 K961015 May 15, 1996 ChoICE Exchange K950113 March 31, 1995 K961015 May 15, 1996 CholCE PT Vision K962572 Currently…	Scimed Life Systems, Inc.	1995	—
*	K950113	Scimed (R) Chice (TM) Exchange Ptca Guide Wire Summary page 2 …510(k) Clearance Date ChoICE K943192 November 22, 1994 K950141 March 3, 1995 K961015 May 15, 1996 CholCE Plus K945129 March 3, 1995 K961015 May 15, 1996 ChoICE Exchange K950113 March 31, 1995 K961015 May 15, 1996 CholCE PT Vision K962572 Currently under review. . Device The ChoICE Super Support and Super…	Scimed Life Systems, Inc.	1995	—

Also cleared against K943192: 4 other devices →

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K090554	Acuity Mailman and Strait-Trak Guidewire	Boston Scientific Corp	2009	1
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?

None of the 5 ancestors has a recall.
Of its descendants, K090554 (Boston Scientific Corp, 2009) has gone furthest, with 1 descendant of its own.
4 other devices also cite its predicate K943192.

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 ChoICE Guide Wires are intended to facilitate the placement 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.

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/K964551 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964551: Choice Super Support Ptca Guide Wire, Choice Plus Super Support Ptca Guide Wire, Choice Exchange Super Support Ptca Guid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964551

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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