510(k) Report

510(k) · Cleared

Cleared

.010 Silverspeed Hydropophilic Guidewire, .014 Silversped Hydrophilic Guidewire, .016 Silverspeed Hydrophilic Guidewi

K993257510(k) SpecialCleared Oct 21, 199922-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

Micro Therapeutics, Inc. · DQX Wire, Guide, Catheter

Cleared on Oct 21, 1999 after a 22-day review. The FDA summary names its predicate without a number. 16 later devices descend from it.

Decided
Oct 21, 1999
Review
22 days
Class
Class II
Product code
DQX
Recalls
None
Predicates
0

16 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2013: 1 descendant cleared2011: 2 descendants cleared2010: 1 descendant cleared2015: 1 descendant cleared2012: 1 descendant cleared2019: 2 descendants cleared2016: 3 descendants cleared2024: 1 descendant cleared2020: 2 descendants cleared2017: 1 descendant cleared2025: 1 descendant cleared1995200020052010201520202025
  1. This deviceK993257 .010 Silverspeed Hydropophilic Guidewire, .014 Silversped…Micro Therapeutics, Inc. · 1999
  2. Descendant · cites it directly · 11 of its ownK110584 Asahi Chikai Neurovascular Guide WireAsahi Intecc Co., Ltd. · 2011
  3. Descendant · cites it directly · 6 of its ownK112979 Asahi Chikai 10 Neurovascular Guide WireAsahi Intecc Co., Ltd. · 2011
  4. Descendant · cites it directly · 4 of its ownK141751 Asahi Neurovascular Guide Wire Asahi Chikai 008, Asahi Neurovascular…Asahi Intecc Co., Ltd. · 2015
  5. Descendant · cites it directly · 2 of its ownK124007 Silverspeed Hydrophilic Guidewire, X-Celerator Hydrophilic Exchange…Micro Therapeutics, Inc. D/B/A: Ev3, Inc. · 2013
  6. Descendant · 2 generations on · 1 of its ownK193548 Mirage Hydrophilic Guidewire, X-pedion Hydrophilic GuidewireMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2020

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2010: 12011: 22012: 12013: 12015: 12016: 32017: 12019: 22020: 22024: 12025: 1
2010high 3 (2016) · low 0 (2014)2026

Most influential descendants

Showing 5 of 16 · See all
  • K110584Asahi Chikai Neurovascular Guide WireAsahi Intecc Co., Ltd. · 2011 · cites it directly11descendants
  • K112979Asahi Chikai 10 Neurovascular Guide WireAsahi Intecc Co., Ltd. · 2011 · cites it directly6descendants
  • K141751Asahi Neurovascular Guide Wire Asahi Chikai 008, Asahi Neurovascular Guide Wire Asahi…Asahi Intecc Co., Ltd. · 2015 · cites it directly4descendants
  • K124007Silverspeed Hydrophilic Guidewire, X-Celerator Hydrophilic Exchange Guidewire, X-Pedion…Micro Therapeutics, Inc. D/B/A: Ev3, Inc. · 2013 · cites it directly2descendants
  • K193548Mirage Hydrophilic Guidewire, X-pedion Hydrophilic GuidewireMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2020 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K993257.010 Silverspeed Hydropophilic Guidewire, .014 Silversped Hydrophilic…Micro Therapeutics, Inc.1999—
+1K110584Asahi Chikai Neurovascular Guide WireAsahi Intecc Co., Ltd.2011—
+1K112979Asahi Chikai 10 Neurovascular Guide WireAsahi Intecc Co., Ltd.2011—
+1K141751Asahi Neurovascular Guide Wire Asahi Chikai 008, Asahi Neurovascular Guide…Asahi Intecc Co., Ltd.2015—
+1K124007Silverspeed Hydrophilic Guidewire, X-Celerator Hydrophilic Exchange Guidewire…Micro Therapeutics, Inc. D/B/A: Ev3, Inc.2013—
+2K193548Mirage Hydrophilic Guidewire, X-pedion Hydrophilic GuidewireMicro Therapeutics, Inc. d/b/a ev3 Neurovascular2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201120
201210
201310
201510
201630
201710
201920
202020
202410
202510
FIG. 1 — Lineage of K993257, 1999–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (2)

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
*—Micro Therapeutics, Inc. .010” SilverSpeed™ Hydrophilic Guidewire
Named without a submission number
—
*—B. Braun Guidewire Introducer & Guidewire Torque Device
Named without a submission number
—

What descends from it? (16)

See all 16

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

NumberDeviceApplicantDecidedDescendants
K110584Asahi Chikai Neurovascular Guide WireAsahi Intecc Co., Ltd.201111
K112979Asahi Chikai 10 Neurovascular Guide WireAsahi Intecc Co., Ltd.20116
K141751Asahi Neurovascular Guide Wire Asahi Chikai 008, Asahi Neurovascular Guide Wire Asahi…Asahi Intecc Co., Ltd.20154
K124007Silverspeed Hydrophilic Guidewire, X-Celerator Hydrophilic Exchange Guidewire, X-Pedion…Micro Therapeutics, Inc. D/B/A: Ev3, Inc.20132
K113716Asahi Chikai V Peripheral Vascular Guide WireAsahi Intecc Co., Ltd.20121
K093681Meridian GuidewireEv3 Neurovascular20100

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, K110584 (Asahi Intecc Co., Ltd., 2011) has gone furthest, with 11 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

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 SilverSpeed Hydrophilic Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Micro Therapeutics, Inc.

51 FDA decisions under this applicant name. See the company

  • K113289Orion Micro CatheterMicro Therapeutics, Inc. · 2012
  • K11345414 Wire Standard, 14 Wire LSMicro Therapeutics, Inc. · 2012
  • K090870Echelon Micro Catheter, Models 105-5092-150SA, 145-5092-150SA and 190-5092-150SA and Syringe Adapter AccessoryMicro Therapeutics, Inc. · 2009
  • K090046Concerto Detachable Coil SystemMicro Therapeutics, Inc. · 2009
  • K081465Axium Detachable Coil SystemMicro Therapeutics, Inc. · 20082 recalls

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/K993257 · printed Nov 4, 2026

Cite this page

510(k) Report. “K993257: .010 Silverspeed Hydropophilic Guidewire, .014 Silversped Hydrophilic Guidewire, .016 Silverspeed Hydrophilic Guidewi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993257

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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