510(k) Report

510(k) · Cleared

Recalled · Class II · 2024

PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide Wires

K032146510(k) AbbreviatedCleared Aug 12, 200329-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

Precision Vascular Systems, Inc. · DQX Wire, Guide, Catheter

Cleared on Aug 12, 2003 as substantially equivalent to K002212 (Micro Therapeutics, Inc., 2000) after a 29-day review. Its family tree reaches back 1 generation to 2000. 28 later devices descend from it. It has been recalled once.

Decided
Aug 12, 2003
Review
29 days
Class
Class II
Product code
DQX
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K002212 (2000). 28 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2026: 10 descendants cleared2005: 1 descendant cleared2018: 2 descendants cleared2019: 3 descendants cleared2023: 4 descendants cleared2020: 2 descendants cleared2025: 4 descendants cleared2024: 1 descendant clearedK002212 · Mirage Hydrophilic Guidewire, Model 103-0608 · Micro Therapeutics, Inc. · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 4 descendants2 generations forward: 9 descendants3 generations forward: 6 descendants4 generations forward: 3 descendants5 generations forward: 5 descendants6 generations forward: 1 descendant K002212 · Mirage Hydrophilic Guidewire, Model 103-0608 · Micro Therapeutics, Inc. · 20000+5
  1. Root · 1 generation backK002212 Mirage Hydrophilic Guidewire, Model 103-0608Micro Therapeutics, Inc. · 2000
  2. This deviceK032146 PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide WiresPrecision Vascular Systems, Inc. · 2003
  3. Descendant · cites it directly · 16 of its ownK173235 Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire…Scientia Vascular, LLC · 2018
  4. Descendant · 2 generations on · 13 of its ownK183608 Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18…Scientia Vascular, LLC · 2019
  5. Descendant · 3 generations on · 12 of its ownK192783 Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24…Scientia Vascular, LLC · 2019
  6. Descendant · cites it directly · 10 of its ownK050964 PV 1900 Synchro 0.016 GuidewireBoston Scientific - Precision Vascular · 2005 · Recalled
  7. Descendant · cites it directly · 9 of its ownK053268 PVS 2000 SYNCHRO2 GuidewireBoston Scientific - Precision Vascular · 2006 · Recalled

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12018: 22019: 32020: 22023: 42024: 12025: 42026: 10
2005high 10 (2026) · low 0 (2007)2026

Most influential descendants

Showing 5 of 28 · See all
  • K173235Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support…Scientia Vascular, LLC · 2018 · cites it directly16descendants
  • K183608Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard…Scientia Vascular, LLC · 2019 · 2 generations on13descendants
  • K192783Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard…Scientia Vascular, LLC · 2019 · 3 generations on12descendants
  • K050964PV 1900 Synchro 0.016 GuidewireBoston Scientific - Precision Vascular · 2005 · cites it directly10descendants
  • K053268PVS 2000 SYNCHRO2 GuidewireBoston Scientific - Precision Vascular · 2006 · cites it directly9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K002212Mirage Hydrophilic Guidewire, Model 103-0608Micro Therapeutics, Inc.2000—
0 (this device)K032146PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide WiresPrecision Vascular Systems, Inc.2003—
+1K173235Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm…Scientia Vascular, LLC2018—
+2K183608Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm…Scientia Vascular, LLC2019—
+3K192783Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm…Scientia Vascular, LLC2019—
+1K050964PV 1900 Synchro 0.016 GuidewireBoston Scientific - Precision Vascular20056
+1K053268PVS 2000 SYNCHRO2 GuidewireBoston Scientific - Precision Vascular200613

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
201820
201930
202020
202340
202410
202540
2026100
FIG. 1 — Lineage of K032146, 2000–2026Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K002212Mirage Hydrophilic Guidewire, Model 103-0608
Summary page 1
…Predicate Devices Mirage .008" I Micro Therapeutics i K002212; 03 Aug 2000 This information is assumed based on our best, current knowledge. ~~…
Micro Therapeutics, Inc.2000—

Also cleared against K002212: 3 other devices →

What descends from it? (28)

See all 28

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

NumberDeviceApplicantDecidedDescendants
K173235Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support…Scientia Vascular, LLC201816
K050964PV 1900 Synchro 0.016 GuidewireBoston Scientific - Precision Vascular200510
K053268PVS 2000 SYNCHRO2 GuidewireBoston Scientific - Precision Vascular20069
K252122DCwire Micro-guidewireShanghai Achieva Medical Suzhou Co., Ltd.20260

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

Recalls of this device

DateClassRecallRoot causeReason
Apr 18, 2024Class IIZ-1939-2024Component design/selectionStryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K173235 (Scientia Vascular, LLC, 2018) has gone furthest, with 16 descendants of its own.
  • 3 other devices also cite its predicate K002212.

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?

The PVS 1300 Synchro@ 0.014" & PVS 1600 [email protected]" Guidewire series of products are intended for general intravascular use, including the neuro and peripheral vasculature. The device can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

Indications for use as stated in the FDA summary.

Also cleared against K002212

3 other devices cite the same predicate.

  • K141751Asahi Neurovascular Guide Wire Asahi Chikai 008, Asahi Neurovascular Guide Wire Asahi Chikai Black, Asahi…Asahi Intecc Co., Ltd. · 2015
  • K124007Silverspeed Hydrophilic Guidewire, X-Celerator Hydrophilic Exchange Guidewire, X-Pedion Hydrophilic…Micro Therapeutics, Inc. D/B/A: Ev3, Inc. · 2013
  • K023700PVS 1600 Synchro 0.010 Neuro Guide WirePrecision Vascular Systems, Inc. · 20021 recall

More from Precision Vascular Systems, Inc.

7 FDA decisions under this applicant name. See the company

  • K032494PVS 1700 Steerable Delivery System MicrocatheterPrecision Vascular Systems, Inc. · 2003
  • K023700PVS 1600 Synchro 0.010 Neuro Guide WirePrecision Vascular Systems, Inc. · 20021 recall
  • K020733PVS 1500 SDSPrecision Vascular Systems, Inc. · 2002
  • K002907PVS 1300 Neuro Guide WirePrecision Vascular Systems, Inc. · 20011 recall
  • K002707PVS 1400 Guide Wite with Hydrophilic CoatingPrecision Vascular Systems, Inc. · 2000

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/K032146 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032146: PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide Wires.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032146

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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