510(k) Report

510(k) · Cleared

Cleared

Spectranetics Quick-Cross Extreme Support Catheters

K082561510(k) TraditionalCleared Dec 10, 200897-day reviewClass II21 CFR 870.1250

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

Spectranetics Corp. · DQY Catheter, Percutaneous

Cleared on Dec 10, 2008 as substantially equivalent to K991059 (Spectranetics Corp., 1999) and 4 other predicates after a 97-day review. Its family tree reaches back 5 generations to 1994. 18 later devices descend from it.

Decided
Dec 10, 2008
Review
97 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
5

Its longest line of descent runs back 5 generations to K935425 (1994). 11 ancestors in all, the oldest K863137 (1986). 18 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1996: 1 other ancestor1992: 2 other ancestors1986: 1 other ancestor1993: 1 other ancestor2019: 1 descendant cleared2021: 4 descendants cleared2009: 1 descendant cleared2012: 1 descendant cleared2014: 1 descendant cleared2020: 1 descendant cleared2018: 3 descendants cleared2024: 1 descendant cleared2022: 2 descendants cleared2011: 1 descendant cleared2023: 1 descendant cleared2026: 1 descendant clearedK935425 · Metronic Buchbinder Envoy Percutaneous Catheters · Medtronics Interventional Vascular · 1994K991059 · Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018 Support Catheter, Model 518-017 · Spectranetics Corp. · 1999K022138 · Spectranetics 0.035 Support Catheter, Model 518-028 · Spectranetics Corp. · 2002K033678 · Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035, 518-036, 518-037 and 518-038 · Spectranetics Corp. · 2004K072750 · Spectranetics Quick-Cross SUPPORT2 Catheters, Models 518-065 and 518-066 · Spectranetics Corp. · 20071990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors3 generations back: 2 other ancestors 1 generation forward: 6 descendants2 generations forward: 6 descendants3 generations forward: 5 descendants4 generations forward: 1 descendant K072750 · Spectranetics Quick-Cross SUPPORT2 Catheters, Models 518-065 and 518-066 · Spectranetics Corp. · 2007K033678 · Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035, 518-036, 518-037 and 518-038 · Spectranetics Corp. · 2004K022138 · Spectranetics 0.035 Support Catheter, Model 518-028 · Spectranetics Corp. · 2002K991059 · Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018 Support Catheter, Model 518-017 · Spectranetics Corp. · 1999K935425 · Metronic Buchbinder Envoy Percutaneous Catheters · Medtronics Interventional Vascular · 1994−50
  1. Root · 5 generations backK935425 Metronic Buchbinder Envoy Percutaneous CathetersMedtronics Interventional Vascular · 1994
  2. 4 generations backK991059 Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics…Spectranetics Corp. · 1999
  3. 3 generations backK022138 Spectranetics 0.035 Support Catheter, Model 518-028Spectranetics Corp. · 2002
  4. 2 generations backK033678 Spectranetics Quick Cross Catheters, Models 518-032, 518-033…Spectranetics Corp. · 2004
  5. 1 generation backK072750 Spectranetics Quick-Cross SUPPORT2 Catheters, Models 518-065 and…Spectranetics Corp. · 2007
  6. This deviceK082561 Spectranetics Quick-Cross Extreme Support CathetersSpectranetics Corp. · 2008
  7. Descendant · cites it directly · 13 of its ownK092396 Spectranetics Quick Cross Extreme Support CathetersSpectranetics Corp. · 2009
  8. Descendant · 2 generations on · 6 of its ownK110540 Terumo Support CatheterTerumo Medical Corp. · 2011
  9. Descendant · 3 generations on · 2 of its ownK173799 NaviCross 0.018Terumo Corporation · 2018
  10. Descendant · cites it directly · 2 of its ownK133539 Total AcrossMedtronic Vascular · 2014
  11. Descendant · 3 generations on · 1 of its ownK231044 R2P NavicrossTerumo Medical Corporation · 2023

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2009: 12011: 12012: 12014: 12018: 32019: 12020: 12021: 42022: 22023: 12024: 12026: 1
2009high 4 (2021) · low 0 (2010)2026

Most influential descendants

Showing 5 of 18 · See all
  • K092396Spectranetics Quick Cross Extreme Support CathetersSpectranetics Corp. · 2009 · cites it directly13descendants
  • K110540Terumo Support CatheterTerumo Medical Corp. · 2011 · 2 generations on6descendants
  • K173799NaviCross 0.018Terumo Corporation · 2018 · 3 generations on2descendants
  • K133539Total AcrossMedtronic Vascular · 2014 · cites it directly2descendants
  • K231044R2P NavicrossTerumo Medical Corporation · 2023 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K935425Metronic Buchbinder Envoy Percutaneous CathetersMedtronics Interventional Vascular1994—
−4K991059Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018…Spectranetics Corp.1999—
−3K022138Spectranetics 0.035 Support Catheter, Model 518-028Spectranetics Corp.2002—
−2K033678Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035…Spectranetics Corp.2004—
−1K072750Spectranetics Quick-Cross SUPPORT2 Catheters, Models 518-065 and 518-066Spectranetics Corp.2007—
0 (this device)K082561Spectranetics Quick-Cross Extreme Support CathetersSpectranetics Corp.2008—
+1K092396Spectranetics Quick Cross Extreme Support CathetersSpectranetics Corp.2009—
+2K110540Terumo Support CatheterTerumo Medical Corp.2011—
+3K173799NaviCross 0.018Terumo Corporation2018—
+1K133539Total AcrossMedtronic Vascular2014—
+3K231044R2P NavicrossTerumo Medical Corporation2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
199220
199310
199610
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201110
201210
201410
201830
201910
202010
202140
202220
202310
202410
202610
FIG. 1 — Lineage of K082561, 1994–2026Source: 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 DQY? 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 DQY device

  1. #1 K234115 APRO 55 Catheterscore 17.5 · 6 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? (5)

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
*K991059Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018 Support…
Summary page 1
…ercutaneous D. Device Class: Class II (per 21 CFR 870.1330) E. Device Code: DQY CLAIMED EQUIVALENCE Quick-Cross® Support 2 Catheters (K991059, K022138, K033678, and K072750) 4Fr Terumo RadiFocus Optitorque (K992051) DEVICE DESCRIPTION Specifications:…
Spectranetics Corp.1999—
*K022138Spectranetics 0.035 Support Catheter, Model 518-028
Summary page 1
…us D. Device Class: Class II (per 21 CFR 870.1330) E. Device Code: DQY CLAIMED EQUIVALENCE Quick-Cross® Support 2 Catheters (K991059, K022138, K033678, and K072750) 4Fr Terumo RadiFocus Optitorque (K992051) DEVICE DESCRIPTION Specifications:…
Spectranetics Corp.2002—
*K033678Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035, 518-036…
Summary page 1
…D. Device Class: Class II (per 21 CFR 870.1330) E. Device Code: DQY CLAIMED EQUIVALENCE Quick-Cross® Support 2 Catheters (K991059, K022138, K033678, and K072750) 4Fr Terumo RadiFocus Optitorque (K992051) DEVICE DESCRIPTION Specifications:…
Spectranetics Corp.2004—
*K072750Spectranetics Quick-Cross SUPPORT2 Catheters, Models 518-065 and 518-066
Summary page 1
…ss: Class II (per 21 CFR 870.1330) E. Device Code: DQY CLAIMED EQUIVALENCE Quick-Cross® Support 2 Catheters (K991059, K022138, K033678, and K072750) 4Fr Terumo RadiFocus Optitorque (K992051) DEVICE DESCRIPTION Specifications:…
Spectranetics Corp.2007—
*K992051Radifocus Optitorque
Summary page 1
…Code: DQY CLAIMED EQUIVALENCE Quick-Cross® Support 2 Catheters (K991059, K022138, K033678, and K072750) 4Fr Terumo RadiFocus Optitorque (K992051) DEVICE DESCRIPTION Specifications: Max. (OD) Working Guide Wire *Max…
Terumo Medical Corp.1999—

Also cleared against K991059: 6 other devices →

What descends from it? (18)

See all 18

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

NumberDeviceApplicantDecidedDescendants
K092396Spectranetics Quick Cross Extreme Support CathetersSpectranetics Corp.200913
K133539Total AcrossMedtronic Vascular20142
K211240ViperCross Support CathetersCardiovascular Systems, Inc.20211
K193420XO Cross Support CatheterTransit Scientific20201
K183305Crossing Support CatheterTractus Vascular, LLC20190
K112886Upstream Support CatheterUpstream Peripheral Technologies20120

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 14 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
  • 1 of the 11 ancestors has a recall of any class.
  • Of its descendants, K092396 (Spectranetics Corp., 2009) has gone furthest, with 13 descendants of its own.
  • 6 other devices also cite its predicate K991059.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · DQY

21in 2025

2007: 162008: 312009: 372010: 222011: 362012: 302013: 322014: 192015: 272016: 222017: 262018: 252019: 302020: 202021: 182022: 182023: 182024: 162025: 212026 (partial year): 11
2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007: 85 days median2008: 66 days median2009: 73 days median2010: 74 days median2011: 71 days median2012: 87 days median2013: 92 days median2014: 127 days median2015: 118 days median2016: 117 days median2017: 113 days median2018: 106 days median2019: 111 days median2020: 120 days median2021: 81 days median2022: 74 days median2023: 114 days median2024: 87 days median2025: 115 days median2026 (partial year): 30 days median
2007high 127 (2014) · low 66 (2008)2026

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

Recalls per year · DQY

1in 2025

2007: 62008: 122009: 172010: 322011: 62012: 22013: 36, 1 Class I2014: 32015: 32016: 22, 7 Class I2017: 82018: 22019: 12020: 22021: 22023: 172024: 12025: 1, 1 Class I2026 (partial year): 2, 1 Class I
2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007: 3132008: 4962009: 8192010: 1,2932011: 1,2112012: 1,1912013: 1,3522014: 1,4972015: 2,3372016: 2,2522017: 2,4892018: 2,8552019: 2,9022020: 2,8892021: 3,0062022: 2,6432023: 3,0492024: 3,1902025: 3,056
2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, 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
200716856313
2008316612496
2009377317819
20102274321,293
2011367161,211
2012308721,191
2013329236 (1)1,352
20141912731,497
20152711832,337
20162211722 (7)2,252
20172611382,489
20182510622,855
20193011112,902
20202012022,889
2021188123,006
2022187402,643
202318114173,049
2024168713,190
2025211151 (1)3,056
202611302 (1)—

What is it indicated for?

Quick-Cross ® Extreme Support Catheters are intended to guide and support a

guide wire during access of the vasculature, allow for wire exchanges and provide

a conduit for the delivery of saline solutions or diagnostic contrast agents.

Indications for use as stated in the FDA summary.

Also cleared against K991059

6 other devices cite the same predicate.

  • K082337Minnie Support CatheterVascular Solutions, Inc. · 2009
  • K072750Spectranetics Quick-Cross SUPPORT2 Catheters, Models 518-065 and 518-066Spectranetics Corp. · 2007
  • K033540Transxchange Support CatheterMedtronic Vascular · 2004
  • K033678Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035, 518-036, 518-037 and 518-038Spectranetics Corp. · 2004
  • K022138Spectranetics 0.035 Support Catheter, Model 518-028Spectranetics Corp. · 2002
  • K013284Lumend Frontrunner Cto Coronary CatheterLumend, Inc. · 2002

More from Spectranetics Corp.

183 FDA decisions under this applicant name. See the company

  • P910001/S127Philips Laser SystemSpectranetics Corp. · 2026
  • P910001/S126ELCA Coronary Laser Atherectomy CathetersSpectranetics Corp. · 2026
  • P910001/S124ELCA Coronary Atherectomy CathetersSpectranetics Corp. · 2026
  • P910001/S125ELCA Coronary Atherectomy CathetersSpectranetics Corp. · 2025
  • P050018/S035AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic CoatingSpectranetics Corp. · 2025

Recent decisions in DQY

The DQY category page

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  • K260559NHanceITIMDS Operation B.V. · 2026
  • K262392APRO 35 Swift CatheterAlembic, LLC · 2026
  • K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC · 2026
  • K262240SSPC NXT Delivery CatheterCenterPoint Systems, LLC · 2026

https://510kreport.com/device/K082561 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082561: Spectranetics Quick-Cross Extreme Support Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082561

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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