510(k) Report

510(k) · Cleared

Cleared

Skipper and Skipper Race Guidewire

K050756510(k) TraditionalCleared May 5, 200543-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

Invatec Innovative Technologies, S.R.L. · DQX Wire, Guide, Catheter

Cleared on May 5, 2005 as substantially equivalent to K024021 (Ev3 Corporation, 2003) and 2 other predicates after a 43-day review. Its family tree reaches back 4 generations to 1997. 10 later devices descend from it.

Decided
May 5, 2005
Review
43 days
Class
Class II
Product code
DQX
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K970376 (1997). 9 ancestors in all, the oldest K893626 (1989). 10 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 2 other ancestors1995: 1 other ancestor1991: 1 other ancestor1989: 1 other ancestor2006: 1 descendant cleared2016: 1 descendant cleared2011: 1 descendant cleared2010: 2 descendants cleared2009: 1 descendant cleared2014: 1 descendant cleared2012: 2 descendants cleared2026: 1 descendant clearedK970376 · Ptca Guidewire · Lake Region Mfg., Inc. · 1997K011968 · Streerable Ptca Guidewire · Lake Region Mfg., Inc. · 2001 · recalledK022813 · Steerable Guidewire · Lake Region Mfg., Inc. · 2003K040345 · Modification to Nitrex Nitinol Guidewire · Ev3, Inc. · 20041990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 5 descendants3 generations forward: 4 descendants K040345 · Modification to Nitrex Nitinol Guidewire · Ev3, Inc. · 2004K022813 · Steerable Guidewire · Lake Region Mfg., Inc. · 2003K011968 · Streerable Ptca Guidewire · Lake Region Mfg., Inc. · 2001 · recalledK970376 · Ptca Guidewire · Lake Region Mfg., Inc. · 19970
  1. Root · 4 generations backK970376 Ptca GuidewireLake Region Mfg., Inc. · 1997
  2. 3 generations backK011968 Streerable Ptca GuidewireLake Region Mfg., Inc. · 2001 · Recalled
  3. 2 generations backK022813 Steerable GuidewireLake Region Mfg., Inc. · 2003
  4. 1 generation backK040345 Modification to Nitrex Nitinol GuidewireEv3, Inc. · 2004
  5. This deviceK050756 Skipper and Skipper Race GuidewireInvatec Innovative Technologies, S.R.L. · 2005
  6. Descendant · cites it directly · 9 of its ownK060551 Brivant GuidewireBrivant Limited · 2006
  7. Descendant · 2 generations on · 3 of its ownK083094 Streamer Polymer GuidewireBrivant, Ltd. · 2009
  8. Descendant · 2 generations on · 2 of its ownK103377 Charter Guidewire Model 45-281, 45-282, 45-283Brivant, Ltd. · 2011
  9. Descendant · 2 generations on · 1 of its ownK160643 ENROUTE 0.014 GuidewireLake Region Medical · 2016
  10. Descendant · 2 generations on · 1 of its ownK102211 Cruiser 18 GuidewireBrivant, Ltd. · 2010

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2006: 12009: 12010: 22011: 12012: 22014: 12016: 12026: 1
2006high 2 (2010) · low 0 (2007)2026

Most influential descendants

Showing 5 of 10 · See all
  • K060551Brivant GuidewireBrivant Limited · 2006 · cites it directly9descendants
  • K083094Streamer Polymer GuidewireBrivant, Ltd. · 2009 · 2 generations on3descendants
  • K103377Charter Guidewire Model 45-281, 45-282, 45-283Brivant, Ltd. · 2011 · 2 generations on2descendants
  • K160643ENROUTE 0.014 GuidewireLake Region Medical · 2016 · 2 generations on1descendant
  • K102211Cruiser 18 GuidewireBrivant, Ltd. · 2010 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K970376Ptca GuidewireLake Region Mfg., Inc.1997—
−3K011968Streerable Ptca GuidewireLake Region Mfg., Inc.20012
−2K022813Steerable GuidewireLake Region Mfg., Inc.2003—
−1K040345Modification to Nitrex Nitinol GuidewireEv3, Inc.2004—
0 (this device)K050756Skipper and Skipper Race GuidewireInvatec Innovative Technologies, S.R.L.2005—
+1K060551Brivant GuidewireBrivant Limited2006—
+2K083094Streamer Polymer GuidewireBrivant, Ltd.2009—
+2K103377Charter Guidewire Model 45-281, 45-282, 45-283Brivant, Ltd.2011—
+2K160643ENROUTE 0.014 GuidewireLake Region Medical2016—
+2K102211Cruiser 18 GuidewireBrivant, Ltd.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199110
199510
200320

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200910
201020
201110
201220
201410
201610
202610
FIG. 1 — Lineage of K050756, 1997–2026Source: 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? (3)

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
*K024021Nitrex Nitinol Guidewire
Summary page 2
…esting to demonstrate equivalency. Statement of Equivalence: The SKIPPER and SKIPPER RACE guidewires are substantially equivalent to the ev3 NitrexTM Nitinol Guidewire (K024021, K031864, K040345) in intended use, materials, technological characteristics and performance. SKIPPER and SKIPPER RACE Guide…
Ev3 Corporation2003—
*K031864Nitrex Nitinol Guidewire
Summary page 1
…Catheter, Guidewire Class: Class 11, 21 CFR 870.1330 Predicate Device: ev3 NitreXTm Nitinol Guidewire (K(024021, K031864,1(040345) This summary is provided in compliance with section 513(I)(3)(A) of the Act and summarizes the safety and effectivenes…
Ev3 Corporation2003—
*K040345Modification to Nitrex Nitinol Guidewire
Summary page 2
…ate equivalency. Statement of Equivalence: The SKIPPER and SKIPPER RACE guidewires are substantially equivalent to the ev3 NitrexTM Nitinol Guidewire (K024021, K031864, K040345) in intended use, materials, technological characteristics and performance. SKIPPER and SKIPPER RACE Guidewires === Page 3…
Ev3, Inc.2004—

Also cleared against K024021: 2 other devices →

What descends from it? (10)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K060551Brivant GuidewireBrivant Limited20069

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?

  • The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
  • 1 of the 9 ancestors has a recall of any class.
  • Of its descendants, K060551 (Brivant Limited, 2006) has gone furthest, with 9 descendants of its own.
  • 2 other devices also cite its predicate K024021.

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 SKIPPER and SKIPPER RACE guidewires are intended for use in the coronary and peripheral vasculature.

Indications for use as stated in the FDA summary.

Also cleared against K024021

2 other devices cite the same predicate.

  • K040345Modification to Nitrex Nitinol GuidewireEv3, Inc. · 2004
  • K031864Nitrex Nitinol GuidewireEv3 Corporation · 2003

More from Invatec Innovative Technologies, S.R.L.

7 FDA decisions under this applicant name. See the company

  • K083919Amphirion Deep 0.014 Otw Pta Balloon CatheterInvatec Innovative Technologies, S.R.L. · 20091 recall
  • K052791Modification to: Amphirion Deep 0.014 Otw Pta Balloon CatheterInvatec Innovative Technologies, S.R.L. · 20051 recall
  • K051917Diver C.E. CatheterInvatec Innovative Technologies, S.R.L. · 20051 recall
  • K050276Diver C.E. CatheterInvatec Innovative Technologies, S.R.L. · 20051 recall
  • K050073Modification to Amphirion Deep 0.014 Otw Pta Balloon CatheterInvatec Innovative Technologies, S.R.L. · 20051 recall

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The DQX category page

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https://510kreport.com/device/K050756 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050756: Skipper and Skipper Race Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050756

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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