510(k) · Cleared

Cleared

Scimed Choice Family of Ptca Guide Wires

K970244510(k) TraditionalCleared Mar 28, 199765-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 28, 1997 as substantially equivalent to K943192 (Scimed Life Systems, Inc., 1994) and 9 other predicates after a 65-day review. Its family tree reaches back 1 generation to 1994. 1 of the 21 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it.

Decided: Mar 28, 1997
Review: 65 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 10

Its longest line of descent runs back 1 generation to K941895 (1994). 10 ancestors in all. 10 later devices descend from it, 2 citing it directly. 1 of the 21 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK941895 Scimed 0.014 Ptca Guide Wire with Ice Hydrophilic CoatingScimed Life Systems, Inc. · 1994
This deviceK970244 Scimed Choice Family of Ptca Guide WiresScimed Life Systems, Inc. · 1997
Descendant · cites it directly · 8 of its ownK021363 Endovascular Guide WireStereotaxis, Inc. · 2002 · Recalled
Descendant · 2 generations on · 6 of its ownK042854 Stereotaxis Endovascular Guide WireStereotaxis, Inc. · 2005
Descendant · 3 generations on · 2 of its ownK052347 Titan Steerable (Ptca) GuidewireLake Region Mfg., Inc. · 2006
Descendant · 4 generations on · 1 of its ownK060454 Titan GuidewireLake Region Mfg., Inc. · 2006
Descendant · 2 generations on · 1 of its ownK043457 Modification to Endovascular Guide WireStereotaxis, Inc. · 2005

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

1998high 3 (2005) · low 0 (1999)2026

Class I recalls in this family

K080364 Findrwirz Guide Wire System3 generations on · 2008

Most influential descendants

Showing 5 of 10 · See all

K021363Endovascular Guide WireStereotaxis, Inc. · 2002 · cites it directly8descendants
K042854Stereotaxis Endovascular Guide WireStereotaxis, Inc. · 2005 · 2 generations on6descendants
K052347Titan Steerable (Ptca) GuidewireLake Region Mfg., Inc. · 2006 · 3 generations on2descendants
K060454Titan GuidewireLake Region Mfg., Inc. · 2006 · 4 generations on1descendant
K043457Modification to Endovascular Guide WireStereotaxis, Inc. · 2005 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K941895	Scimed 0.014 Ptca Guide Wire with Ice Hydrophilic Coating	Scimed Life Systems, Inc.	1994	—
0 (this device)	K970244	Scimed Choice Family of Ptca Guide Wires	Scimed Life Systems, Inc.	1997	—
+1	K021363	Endovascular Guide Wire	Stereotaxis, Inc.	2002	6
+2	K042854	Stereotaxis Endovascular Guide Wire	Stereotaxis, Inc.	2005	—
+3	K052347	Titan Steerable (Ptca) Guidewire	Lake Region Mfg., Inc.	2006	—
+4	K060454	Titan Guidewire	Lake Region Mfg., Inc.	2006	—
+2	K043457	Modification to Endovascular Guide Wire	Stereotaxis, Inc.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1995	6	0
1996	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2002	1	0
2005	3	0
2006	2	0
2008	3	1

FIG. 1 — Lineage of K970244, 1994–2008Source: 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.

1 device in this family has a Class I recall. 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? (10)

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 …iveness, continued Predicate Devices: Device Description Appendix A The following predicate devices are available from SCIMED. Product 510(k) Clearance Date CholICE K943192 November 22, 1994 K950141 March 3, 1995 K961015 May 15, 1996 K964551 \| Submitted Nov. 14, 1996 CholCE Plus K945129 March 3, 1995…	Scimed Life Systems, Inc.	1994	—
*	K950141	Scimed (R) Choice (TM) Ptca Guide Wire Summary page 2 …ate Devices: Device Description Appendix A The following predicate devices are available from SCIMED. Product 510(k) Clearance Date CholICE K943192 November 22, 1994 K950141 March 3, 1995 K961015 May 15, 1996 K964551 \| Submitted Nov. 14, 1996 CholCE Plus K945129 March 3, 1995 K961015 May 15, 1996 K9645…	Scimed Life Systems, Inc.	1995	—
*	K961015	Scimed Choice/Ptca Guide Wire/Plus Ptca Guide Wire/Exchange Ptca Guide Wire Summary page 2 …escription Appendix A The following predicate devices are available from SCIMED. Product 510(k) Clearance Date CholICE K943192 November 22, 1994 K950141 March 3, 1995 K961015 May 15, 1996 K964551 \| Submitted Nov. 14, 1996 CholCE Plus K945129 March 3, 1995 K961015 May 15, 1996 K964551 \| Submitted Nov. 14…	Scimed Life Systems, Inc.	1996	—
*	K945129	Scimed Chioce Plus Ptca Guide Wire Summary page 2 …le from SCIMED. Product 510(k) Clearance Date CholICE K943192 November 22, 1994 K950141 March 3, 1995 K961015 May 15, 1996 K964551 \| Submitted Nov. 14, 1996 CholCE Plus K945129 March 3, 1995 K961015 May 15, 1996 K964551 \| Submitted Nov. 14, 1996 K965023 \| Submitted Dec. 17,1996 CholICE Exchange K950113 ©…	Scimed Life Systems, Inc.	1995	—
*	K950113	Scimed (R) Chice (TM) Exchange Ptca Guide Wire Summary page 2 …4551 \| Submitted Nov. 14, 1996 CholCE Plus K945129 March 3, 1995 K961015 May 15, 1996 K964551 \| Submitted Nov. 14, 1996 K965023 \| Submitted Dec. 17,1996 CholICE Exchange K950113 © ‘March 31, 1995 K961015 May 15, 1996 K964551 \| Submitted Nov. 14, 1996 CholCE PT K941895 May 24, 1996 K950835 May 25, 1995 K960…	Scimed Life Systems, Inc.	1995	—
*	K941895	Scimed 0.014 Ptca Guide Wire with Ice Hydrophilic Coating Summary page 2 …51 \| Submitted Nov. 14, 1996 K965023 \| Submitted Dec. 17,1996 CholICE Exchange K950113 © ‘March 31, 1995 K961015 May 15, 1996 K964551 \| Submitted Nov. 14, 1996 CholCE PT K941895 May 24, 1996 K950835 May 25, 1995 K960657 April 29, 1996 CholCE PT Plus K950216 June 22, 1995 K960657 April 29, 1996 . K965023 \|…	Scimed Life Systems, Inc.	1994	—
*	K950835	Scimed Choice PT Ptca Guide Wire Summary page 2 …4, 1996 K965023 \| Submitted Dec. 17,1996 CholICE Exchange K950113 © ‘March 31, 1995 K961015 May 15, 1996 K964551 \| Submitted Nov. 14, 1996 CholCE PT K941895 May 24, 1996 K950835 May 25, 1995 K960657 April 29, 1996 CholCE PT Plus K950216 June 22, 1995 K960657 April 29, 1996 . K965023 \| Submitted Dec. 17, 19…	Scimed Life Systems, Inc.	1995	—
*	K960657	Scimed Choice PT Exchange Extra Support Ptca and Long Taper Ptca Guide Wire Summary page 2 …mitted Dec. 17,1996 CholICE Exchange K950113 © ‘March 31, 1995 K961015 May 15, 1996 K964551 \| Submitted Nov. 14, 1996 CholCE PT K941895 May 24, 1996 K950835 May 25, 1995 K960657 April 29, 1996 CholCE PT Plus K950216 June 22, 1995 K960657 April 29, 1996 . K965023 \| Submitted Dec. 17, 1996 CholCE PT Exchange…	Scimed Life Systems, Inc.	1996	1
*	K950216	Scimed Choice PT Plus (RM) Ptca Guide Wire Summary page 2 …950113 © ‘March 31, 1995 K961015 May 15, 1996 K964551 \| Submitted Nov. 14, 1996 CholCE PT K941895 May 24, 1996 K950835 May 25, 1995 K960657 April 29, 1996 CholCE PT Plus K950216 June 22, 1995 K960657 April 29, 1996 . K965023 \| Submitted Dec. 17, 1996 CholCE PT Exchange K950266 April 14, 1996 K960657 April…	Scimed Life Systems, Inc.	1995	—
*	K950266	Scimed (R) Choice (TM) PT Exchange Ptca Guide Wire Summary page 2 …y 24, 1996 K950835 May 25, 1995 K960657 April 29, 1996 CholCE PT Plus K950216 June 22, 1995 K960657 April 29, 1996 . K965023 \| Submitted Dec. 17, 1996 CholCE PT Exchange K950266 April 14, 1996 K960657 April 29, 1996 The ChoICE Guide Wires are steerable guide wires available in a nominal diameter of 0.014…	Scimed Life Systems, Inc.	1995	—

Also cleared against K943192: 4 other devices →

What descends from it? (10)

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

Number	Device	Applicant	Decided	Descendants
K021363	Endovascular Guide Wire	Stereotaxis, Inc.	2002	8
K980360	Scimed Quest Floppy and Moderate Support Guide Wires	Scimed Life Systems, Inc.	1998	0

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K080364Findrwirz Guide Wire SystemSentreheart, Inc. · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall

What does this lineage say?

1 of the 10 ancestors has a recall of any class.
Of its descendants, K021363 (Stereotaxis, Inc., 2002) has gone furthest, with 8 descendants 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 CholCE 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 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/K970244 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970244: Scimed Choice Family of Ptca Guide Wires.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970244

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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