510(k) · Cleared

Recalled · 2006

Micrus Guide Wire, Watusi 0.014

K053265510(k) TraditionalCleared Apr 28, 2006157-day reviewClass II21 CFR 870.1330Recalls 1

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

Micrus Endovascular Corporation · DQX Wire, Guide, Catheter

Cleared on Apr 28, 2006 as substantially equivalent to K971254 (Boston Scientific Corp, 1997) after a 157-day review. Its family tree reaches back 1 generation to 1997. It has been recalled once.

Decided: Apr 28, 2006
Review: 157 days
Class: Class II
Product code: DQX
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K971254 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK971254 Transend EX Platinum GuidewireBoston Scientific Corp · 1997
This deviceK053265 Micrus Guide Wire, Watusi 0.014Micrus Endovascular Corporation · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K971254	Transend EX Platinum Guidewire	Boston Scientific Corp	1997	—
0 (this device)	K053265	Micrus Guide Wire, Watusi 0.014	Micrus Endovascular Corporation	2006	—

FIG. 1 — Lineage of K053265, 1997–2006Source: 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? (1)

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
*	K971254	Transend EX Platinum Guidewire Summary page 1 …Number Description Clearance Date K971254 Transend Ex Platinum 0.014 Guide Wire July 1, 1997 D. Device Description The Micrus guide w…	Boston Scientific Corp	1997	—

Also cleared against K971254: 8 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 8, 2006	Not classified	Z-1542-06	Other	During use, the introducer may cause the guide wire''s coating to strip off and may result in loose material which could break free and enter the blood stream.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
8 other devices also cite its predicate K971254.

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?

Micrus Watusi guide wire is intended for general intravascular use, including the neuro and peripheral vasculature. The Watusi guide wire is not intended for use in the coronary arteries. The guide wire can be torqued to facilitate the selective placement of diagnostic or therapeutic catheters. A torque device (pin vise) is included with the guide wire to facilitate directional manipulation of the guide wire. An introducer device is included to introduce the guide wire into the catheter or hemostatic valve, and can also be used to shape the flexible tip of the guide wire, as desired.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K053265 · printed Nov 4, 2026

Cite this page

510(k) Report. “K053265: Micrus Guide Wire, Watusi 0.014.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053265

Report an extraction error

Are you the manufacturer?

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