510(k) · Cleared

Cleared

Transend Guidewire

K964611510(k) TraditionalCleared Jan 28, 199771-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

Boston Scientific Corp · DQX Wire, Guide, Catheter

Cleared on Jan 28, 1997 after a 71-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.

Decided: Jan 28, 1997
Review: 71 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 0

2 later devices descend from it, 2 citing it directly.

This deviceK964611 Transend GuidewireBoston Scientific Corp · 1997
Descendant · cites it directly · 0 of its ownK113454 14 Wire Standard, 14 Wire LSMicro Therapeutics, Inc. · 2012
Descendant · cites it directly · 0 of its ownK023700 PVS 1600 Synchro 0.010 Neuro Guide WirePrecision Vascular Systems, Inc. · 2002 · Recalled

Most influential descendants

Showing 2 of 2 · See all

K11345414 Wire Standard, 14 Wire LSMicro Therapeutics, Inc. · 2012 · cites it directly0descendants
K023700PVS 1600 Synchro 0.010 Neuro Guide WirePrecision Vascular Systems, Inc. · 2002 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K964611	Transend Guidewire	Boston Scientific Corp	1997	—
+1	K113454	14 Wire Standard, 14 Wire LS	Micro Therapeutics, Inc.	2012	—
+1	K023700	PVS 1600 Synchro 0.010 Neuro Guide Wire	Precision Vascular Systems, Inc.	2002	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2012	1	0

FIG. 1 — Lineage of K964611, 1997–2012Source: 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? (4)

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	Recalls
*	—	BSC Transend Guidewire Named without a submission number	—
*	—	Target Therapeutics Dasher-10 and Seeker-Lite Guidewires Named without a submission number	—
*	—	Terumo Corporation’s Glidewire Gold Guidewire Named without a submission number	—
*	—	Micro Interventional Systems Quicksilver Guidewire Named without a submission number	—

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
K113454	14 Wire Standard, 14 Wire LS	Micro Therapeutics, Inc.	2012	0
K023700	PVS 1600 Synchro 0.010 Neuro Guide Wire	Precision Vascular Systems, Inc.	2002	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?

Of its descendants, K113454 (Micro Therapeutics, Inc., 2012) has gone furthest, with 0 descendants of its own.

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 BSC Transend Steerable Guidewire with hydrophilic coating and accessories are intended for general intravascular use including the peripheral and neurovasculature. The devices will be provided sterile, and are intended for one procedure use 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/K964611 · printed Nov 6, 2026

Cite this page

510(k) Report. “K964611: Transend Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964611

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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