510(k) Report

510(k) · Cleared

Cleared

JS Vascular Guide Wire Vise/Torque Device

K032411510(k) TraditionalCleared Oct 7, 200363-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

Js Vascular, Inc. · DQX Wire, Guide, Catheter

Cleared on Oct 7, 2003 as substantially equivalent to K910969 (Terumo Corp., 1991) and 5 other predicates after a 63-day review. Its family tree reaches back 1 generation to 1986. 28 later devices descend from it.

Decided
Oct 7, 2003
Review
63 days
Class
Class II
Product code
DQX
Recalls
None
Predicates
6

Its longest line of descent runs back 1 generation to K861606 (1986). 6 ancestors in all. 28 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1995: 1 other ancestor1993: 1 other ancestor1991: 1 other ancestor1986: 1 other ancestor2006: 1 descendant cleared2010: 3 descendants cleared2009: 1 descendant cleared2014: 2 descendants cleared2017: 2 descendants cleared2022: 2 descendants cleared2011: 2 descendants cleared2012: 5 descendants cleared2020: 2 descendants cleared2016: 3 descendants cleared2015: 1 descendant cleared2023: 2 descendants cleared2018: 1 descendant cleared2021: 1 descendant clearedK861606 · Schneider-Shiley Wire Torquer · Shiley, Inc. · 19861990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 4 descendants4 generations forward: 4 descendants5 generations forward: 2 descendants6 generations forward: 3 descendants7 generations forward: 3 descendants8 generations forward: 5 descendants9 generations forward: 2 descendants10 generations forward: 1 descendant K861606 · Schneider-Shiley Wire Torquer · Shiley, Inc. · 19860+5+10
  1. Root · 1 generation backK861606 Schneider-Shiley Wire TorquerShiley, Inc. · 1986
  2. This deviceK032411 JS Vascular Guide Wire Vise/Torque DeviceJs Vascular, Inc. · 2003
  3. Descendant · cites it directly · 22 of its ownK060745 Asahi Tornus Support Catheter with Torque Device AccessoryAsahi Intecc Co., Ltd. · 2006
  4. Descendant · 2 generations on · 21 of its ownK083313 Wildcat 7F Guidewire Support CatheterAvinger, Inc. · 2009
  5. Descendant · 3 generations on · 18 of its ownK102022 Wildcat 6F Guidewire Support Catheter Model W400L and W400SAvinger, Inc. · 2010
  6. Descendant · 4 generations on · 17 of its ownK111338 Wildcat CatheterAvinger, Inc. · 2011
  7. Descendant · 5 generations on · 14 of its ownK122380 Ocelot SystemAvinger, Inc. · 2012

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2006: 12009: 12010: 32011: 22012: 52014: 22015: 12016: 32017: 22018: 12020: 22021: 12022: 22023: 2
2006high 5 (2012) · low 0 (2007)2026

Most influential descendants

Showing 5 of 28 · See all
  • K060745Asahi Tornus Support Catheter with Torque Device AccessoryAsahi Intecc Co., Ltd. · 2006 · cites it directly22descendants
  • K083313Wildcat 7F Guidewire Support CatheterAvinger, Inc. · 2009 · 2 generations on21descendants
  • K102022Wildcat 6F Guidewire Support Catheter Model W400L and W400SAvinger, Inc. · 2010 · 3 generations on18descendants
  • K111338Wildcat CatheterAvinger, Inc. · 2011 · 4 generations on17descendants
  • K122380Ocelot SystemAvinger, Inc. · 2012 · 5 generations on14descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K861606Schneider-Shiley Wire TorquerShiley, Inc.1986—
0 (this device)K032411JS Vascular Guide Wire Vise/Torque DeviceJs Vascular, Inc.2003—
+1K060745Asahi Tornus Support Catheter with Torque Device AccessoryAsahi Intecc Co., Ltd.2006—
+2K083313Wildcat 7F Guidewire Support CatheterAvinger, Inc.2009—
+3K102022Wildcat 6F Guidewire Support Catheter Model W400L and W400SAvinger, Inc.2010—
+4K111338Wildcat CatheterAvinger, Inc.2011—
+5K122380Ocelot SystemAvinger, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
199110
199310
199510
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200910
201030
201120
201250
201420
201510
201630
201720
201810
202020
202110
202220
202320
FIG. 1 — Lineage of K032411, 1986–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K213854 SavvyWirescore 15.7 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K910969Torque Device for a Guide Wire
Summary page 1
…re ViseTM is substantially equivalent in intended use and method of operation to the following predicate devices: Tenuno Corp. Torque Device for a Guide Wire (K9 10969) Boston Scientific WireClipTMTorquer (K003898) Advanced Cardiovascular Services ACS Torque Device (K950752)…
Terumo Corp.1991—
*K003398Wireclip Torquer
Our reading of the summary gave K003898, FDA’s number for Ebi Vuecath Spinal Endoscopic System (Ebi, L.P.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Boston Scientific WireClip Torquer”.
Boston Scientific Corporation Northwest Technology2000—
*K950752Acs Torque Device, Acs Guide Wire Introducer, Acs Guide Wire Accessory Kits
Summary page 1
…enuno Corp. Torque Device for a Guide Wire (K9 10969) Boston Scientific WireClipTMTorquer (K003898) Advanced Cardiovascular Services ACS Torque Device (K950752) Schneider-Shiley Wire Torquer (K86 1606) Advanced Cardiovascular Services Snap-on Torquer (K862409) P…
Advanced Cardiovascular Systems, Inc.19951
*K861606Schneider-Shiley Wire Torquer
Summary page 1
…969) Boston Scientific WireClipTMTorquer (K003898) Advanced Cardiovascular Services ACS Torque Device (K950752) Schneider-Shiley Wire Torquer (K86 1606) Advanced Cardiovascular Services Snap-on Torquer (K862409) Procedure Products Torque Device (K922356) JS…
Shiley, Inc.1986—
*K862409Snap-on Torquer
Summary page 1
…Advanced Cardiovascular Services ACS Torque Device (K950752) Schneider-Shiley Wire Torquer (K86 1606) Advanced Cardiovascular Services Snap-on Torquer (K862409) Procedure Products Torque Device (K922356) JS Vascular, Inc. Guide Wire ViseTM 510(k) Submission. 08/4/03…
Advanced Cardiovascular Systems, Inc.1986—
*K922356Flow Control Valve, Cat. NO. Acv-38
Summary page 1
…K950752) Schneider-Shiley Wire Torquer (K86 1606) Advanced Cardiovascular Services Snap-on Torquer (K862409) Procedure Products Torque Device (K922356) JS Vascular, Inc. Guide Wire ViseTM 510(k) Submission. 08/4/03 Page 4 of 25 Device Des…
American Omni Medical, Inc.1993—

Also cleared against K910969: 3 other devices →

What descends from it? (28)

See all 28

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

NumberDeviceApplicantDecidedDescendants
K060745Asahi Tornus Support Catheter with Torque Device AccessoryAsahi Intecc Co., Ltd.200622
K100093Vsi Torque DeviceVascular Solutions, Inc.20104

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?

  • 1 of the 6 ancestors has a recall of any class.
  • Of its descendants, K060745 (Asahi Intecc Co., Ltd., 2006) has gone furthest, with 22 descendants of its own.
  • 3 other devices also cite its predicate K910969.

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

2007: 142008: 192009: 182010: 212011: 182012: 202013: 182014: 182015: 152016: 142017: 192018: 192019: 132020: 142021: 62022: 152023: 102024: 112025: 102026 (partial year): 12
2007high 21 (2010) · low 6 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQX

177in 2025

2007: 85 days median2008: 87 days median2009: 87 days median2010: 63 days median2011: 43 days median2012: 62 days median2013: 119 days median2014: 103 days median2015: 112 days median2016: 179 days median2017: 85 days median2018: 114 days median2019: 173 days median2020: 106 days median2021: 161 days median2022: 212 days median2023: 136 days median2024: 134 days median2025: 177 days median2026 (partial year): 145 days median
2007high 212 (2022) · low 43 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQX

3in 2024

2007: 122008: 72009: 492010: 342011: 32012: 52013: 7, 4 Class I2015: 12016: 2, 2 Class I2017: 172018: 92019: 22020: 1, 1 Class I2024: 32026 (partial year): 4, 1 Class I
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

2007: 7602008: 7152009: 6872010: 9872011: 1,3112012: 1,3372013: 1,4742014: 1,3232015: 1,3232016: 1,4662017: 1,5242018: 1,7372019: 1,6792020: 1,5362021: 1,7132022: 1,6472023: 2,0682024: 2,2102025: 2,178
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007148512760
200819877715
2009188749687
2010216334987
2011184331,311
2012206251,337
2013181197 (4)1,474
20141810301,323
20151511211,323
2016141792 (2)1,466
20171985171,524
20181911491,737
20191317321,679
2020141061 (1)1,536
2021616101,713
20221521201,647
20231013602,068
20241113432,210
20251017702,178
2026121454 (1)—

What is it indicated for?

This device is intended for use as a torque device for guidewires with a diameter of 0,014 - 0.038” to facilitate twisting and advancing the guidewire during a procedure.

Indications for use as stated in the FDA summary.

Also cleared against K910969

3 other devices cite the same predicate.

  • K220934RADIFOCUS Torque DeviceTerumo Medical Products (Hangzhou) Co., Ltd. · 2022
  • K143252Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (orange)Needle Tech Products, Inc. · 2015
  • K112674Navis TorquerNavis Medical,Inc · 2012

Recent decisions in DQX

The DQX category page

  • K260168Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14)Skycade Med Corporation · 2026
  • K253146Hyperdrive 35 GuidewireRapid-Medical, Ltd. · 2026
  • K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd. · 2026
  • K253667Accoat Guide WireSp Medical A/S · 2026
  • K261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland, Ltd. · 2026

https://510kreport.com/device/K032411 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032411: JS Vascular Guide Wire Vise/Torque Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032411

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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