510(k) · Cleared

Recalled · 2002

Scimed Choice PT Vision Ptca Guide Wire

K962572510(k) TraditionalCleared Dec 17, 1996169-day reviewClass II21 CFR 870.1330Recalls 3

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 Dec 17, 1996 as substantially equivalent to K943192 (Scimed Life Systems, Inc., 1994) and 8 other predicates after a 169-day review. Its family tree reaches back 1 generation to 1994. 16 later devices descend from it. It has been recalled 3 times.

Decided: Dec 17, 1996
Review: 169 days
Class: Class II
Product code: DQX
Recalls: 3
Predicates: 9

Its longest line of descent runs back 1 generation to K941895 (1994). 9 ancestors in all. 16 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK941895 Scimed 0.014 Ptca Guide Wire with Ice Hydrophilic CoatingScimed Life Systems, Inc. · 1994
This deviceK962572 Scimed Choice PT Vision Ptca Guide WireScimed Life Systems, Inc. · 1996
Descendant · cites it directly · 11 of its ownK030617 PT2 Guide Wire and Addwire Extension WireBoston Scientific Scimed, Inc. · 2003 · Recalled
Descendant · 2 generations on · 6 of its ownK143587 ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT…Boston Scientific Corporation · 2015 · Recalled
Descendant · 2 generations on · 4 of its ownK032183 IQ Hydrophilic Guide WireBoston Scientific Corp · 2003
Descendant · 3 generations on · 3 of its ownK040140 IQ Guide WireBoston Scientific Corp · 2004 · Recalled
Descendant · 3 generations on · 2 of its ownK152231 Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 GuidewireBoston Scientific Corporation · 2016

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

1997high 2 (1998) · low 0 (1999)2026

Most influential descendants

Showing 5 of 16 · See all

K030617PT2 Guide Wire and Addwire Extension WireBoston Scientific Scimed, Inc. · 2003 · cites it directly11descendants
K143587ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix…Boston Scientific Corporation · 2015 · 2 generations on6descendants
K032183IQ Hydrophilic Guide WireBoston Scientific Corp · 2003 · 2 generations on4descendants
K040140IQ Guide WireBoston Scientific Corp · 2004 · 3 generations on3descendants
K152231Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 GuidewireBoston Scientific Corporation · 2016 · 3 generations on2descendants

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)	K962572	Scimed Choice PT Vision Ptca Guide Wire	Scimed Life Systems, Inc.	1996	—
+1	K030617	PT2 Guide Wire and Addwire Extension Wire	Boston Scientific Scimed, Inc.	2003	4
+2	K143587	ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire…	Boston Scientific Corporation	2015	1
+2	K032183	IQ Hydrophilic Guide Wire	Boston Scientific Corp	2003	—
+3	K040140	IQ Guide Wire	Boston Scientific Corp	2004	1
+3	K152231	Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire	Boston Scientific Corporation	2016	—

Other ancestors by year cleared

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	2	0
2003	2	0
2004	1	0
2005	1	0
2008	1	0
2011	1	0
2015	2	0
2016	1	0
2017	1	0
2018	2	0
2019	1	0

FIG. 1 — Lineage of K962572, 1994–2019Source: 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

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What was it cleared against? (9)

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 1 …s: Submitter's Name and Address: Contact Person: Classification Name: Common or Usual Name: Proprietary Name: II. Name of Predicate Devices: 210(k) Reference No, K943192 & K961015 K945129 & K961015 K950113 & K961015 K941895 & K960657 K950216 & K960657 K950266 & K960657 K960563 SCIMED Life Systems…	Scimed Life Systems, Inc.	1994	—
*	K961015	Scimed Choice/Ptca Guide Wire/Plus Ptca Guide Wire/Exchange Ptca Guide Wire Summary page 1 …ter's Name and Address: Contact Person: Classification Name: Common or Usual Name: Proprietary Name: II. Name of Predicate Devices: 210(k) Reference No, K943192 & K961015 K945129 & K961015 K950113 & K961015 K941895 & K960657 K950216 & K960657 K950266 & K960657 K960563 SCIMED Life Systems, Inc. One…	Scimed Life Systems, Inc.	1996	—
*	K945129	Scimed Chioce Plus Ptca Guide Wire Summary page 1 …e and Address: Contact Person: Classification Name: Common or Usual Name: Proprietary Name: II. Name of Predicate Devices: 210(k) Reference No, K943192 & K961015 K945129 & K961015 K950113 & K961015 K941895 & K960657 K950216 & K960657 K950266 & K960657 K960563 SCIMED Life Systems, Inc. One SCIMED P…	Scimed Life Systems, Inc.	1995	—
*	K950113	Scimed (R) Chice (TM) Exchange Ptca Guide Wire Summary page 1 …ntact Person: Classification Name: Common or Usual Name: Proprietary Name: II. Name of Predicate Devices: 210(k) Reference No, K943192 & K961015 K945129 & K961015 K950113 & K961015 K941895 & K960657 K950216 & K960657 K950266 & K960657 K960563 SCIMED Life Systems, Inc. One SCIMED Place Maple Grove,…	Scimed Life Systems, Inc.	1995	—
*	K941895	Scimed 0.014 Ptca Guide Wire with Ice Hydrophilic Coating Summary page 1 …ssification Name: Common or Usual Name: Proprietary Name: II. Name of Predicate Devices: 210(k) Reference No, K943192 & K961015 K945129 & K961015 K950113 & K961015 K941895 & K960657 K950216 & K960657 K950266 & K960657 K960563 SCIMED Life Systems, Inc. One SCIMED Place Maple Grove, Minnesota 55311 C…	Scimed Life Systems, Inc.	1994	—
*	K960657	Scimed Choice PT Exchange Extra Support Ptca and Long Taper Ptca Guide Wire Summary page 1 …n Name: Common or Usual Name: Proprietary Name: II. Name of Predicate Devices: 210(k) Reference No, K943192 & K961015 K945129 & K961015 K950113 & K961015 K941895 & K960657 K950216 & K960657 K950266 & K960657 K960563 SCIMED Life Systems, Inc. One SCIMED Place Maple Grove, Minnesota 55311 Connie J. D…	Scimed Life Systems, Inc.	1996	1
*	K950216	Scimed Choice PT Plus (RM) Ptca Guide Wire Summary page 1 …Common or Usual Name: Proprietary Name: II. Name of Predicate Devices: 210(k) Reference No, K943192 & K961015 K945129 & K961015 K950113 & K961015 K941895 & K960657 K950216 & K960657 K950266 & K960657 K960563 SCIMED Life Systems, Inc. One SCIMED Place Maple Grove, Minnesota 55311 Connie J. Del Toro…	Scimed Life Systems, Inc.	1995	—
*	K950266	Scimed (R) Choice (TM) PT Exchange Ptca Guide Wire Summary page 1 …ame: Proprietary Name: II. Name of Predicate Devices: 210(k) Reference No, K943192 & K961015 K945129 & K961015 K950113 & K961015 K941895 & K960657 K950216 & K960657 K950266 & K960657 K960563 SCIMED Life Systems, Inc. One SCIMED Place Maple Grove, Minnesota 55311 Connie J. Del Toro (612) 494-2656 Ca…	Scimed Life Systems, Inc.	1995	—
*	K960563	Scimed Sceptor & Sceptor Exchange Ptca Guide Wires Summary page 1 …Name: II. Name of Predicate Devices: 210(k) Reference No, K943192 & K961015 K945129 & K961015 K950113 & K961015 K941895 & K960657 K950216 & K960657 K950266 & K960657 K960563 SCIMED Life Systems, Inc. One SCIMED Place Maple Grove, Minnesota 55311 Connie J. Del Toro (612) 494-2656 Catheter Guide Wire…	Scimed Life Systems, Inc.	1996	—

Also cleared against K943192: 4 other devices →

What descends from it? (16)

See all 16

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

Number	Device	Applicant	Decided	Descendants
K030617	PT2 Guide Wire and Addwire Extension Wire	Boston Scientific Scimed, Inc.	2003	11
K965023	Choice PT Plus Ptca Guide Wire and Choice PT Vision Ptca Guide Wire	Scimed Life Systems, Inc.	1997	2
K112745	V-14 Control Wire Guidewire	Boston Scientific Corporation	2011	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 19, 2002	Not classified	Z-0592-03	Other	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	Other	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	Other	Labeled as J tip but may be straight tip.

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 9 ancestors has a recall of any class.
Of its descendants, K030617 (Boston Scientific Scimed, Inc., 2003) has gone furthest, with 11 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 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.

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/K962572 · printed Nov 5, 2026

Cite this page

510(k) Report. “K962572: Scimed Choice PT Vision Ptca Guide Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962572

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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