510(k) Report

510(k) · Cleared

Cleared

Metronic Buchbinder Envoy Percutaneous Catheters

K935425510(k) TraditionalCleared Apr 26, 1994167-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

Medtronics Interventional Vascular · DQY Catheter, Percutaneous

Cleared on Apr 26, 1994 after a 167-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 167 devices in its family, counting itself, has a Class I recall. 166 later devices descend from it.

Decided
Apr 26, 1994
Review
167 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
0

166 later devices descend from it, 2 citing it directly. 1 of the 167 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2002: 2 descendants cleared1999: 1 descendant cleared2003: 3 descendants cleared2008: 2 descendants cleared2004: 4 descendants cleared2007: 4 descendants cleared2009: 7 descendants cleared2011: 9 descendants cleared2013: 4 descendants cleared2005: 4 descendants cleared2012: 14 descendants cleared2024: 6 descendants cleared2016: 8 descendants cleared2010: 7 descendants cleared2014: 9 descendants cleared, 1 with a Class I recall12019: 5 descendants cleared2021: 9 descendants cleared2020: 9 descendants cleared2017: 14 descendants cleared2018: 9 descendants cleared2022: 10 descendants cleared2015: 5 descendants cleared2023: 8 descendants cleared2026: 5 descendants cleared2006: 1 descendant cleared2025: 7 descendants cleared1990200020102020
  1. This deviceK935425 Metronic Buchbinder Envoy Percutaneous CathetersMedtronics Interventional Vascular · 1994
  2. Descendant · cites it directly · 165 of its ownK991059 Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics…Spectranetics Corp. · 1999
  3. Descendant · cites it directly · 108 of its ownK022138 Spectranetics 0.035 Support Catheter, Model 518-028Spectranetics Corp. · 2002
  4. Descendant · 2 generations on · 106 of its ownK033678 Spectranetics Quick Cross Catheters, Models 518-032, 518-033…Spectranetics Corp. · 2004
  5. Descendant · 3 generations on · 80 of its ownK052258 Vascular Solutions Skyway Support CatheterVascular Solutions, Inc. · 2005
  6. Descendant · 2 generations on · 72 of its ownK013284 Lumend Frontrunner Cto Coronary CatheterLumend, Inc. · 2002

Showing 5 of 166 descendants. See all descendants

Descendants cleared per year

1999: 12002: 22003: 32004: 42005: 42006: 12007: 42008: 22009: 72010: 72011: 92012: 142013: 42014: 92015: 52016: 82017: 142018: 92019: 52020: 92021: 92022: 102023: 82024: 62025: 72026: 5
1999high 14 (2012) · low 0 (2000)2026

Class I recalls in this family

  • K141547 Wingman Extendable Tip Support Catheter6 generations on · 2014

Most influential descendants

Showing 5 of 166 · See all
  • K991059Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018 Support…Spectranetics Corp. · 1999 · cites it directly165descendants
  • K022138Spectranetics 0.035 Support Catheter, Model 518-028Spectranetics Corp. · 2002 · cites it directly108descendants
  • K033678Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035, 518-036…Spectranetics Corp. · 2004 · 2 generations on106descendants
  • K052258Vascular Solutions Skyway Support CatheterVascular Solutions, Inc. · 2005 · 3 generations on80descendants
  • K013284Lumend Frontrunner Cto Coronary CatheterLumend, Inc. · 2002 · 2 generations on72descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K935425Metronic Buchbinder Envoy Percutaneous CathetersMedtronics Interventional Vascular1994—
+1K991059Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018…Spectranetics Corp.1999—
+1K022138Spectranetics 0.035 Support Catheter, Model 518-028Spectranetics Corp.2002—
+2K033678Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035…Spectranetics Corp.2004—
+3K052258Vascular Solutions Skyway Support CatheterVascular Solutions, Inc.2005—
+2K013284Lumend Frontrunner Cto Coronary CatheterLumend, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200220
200330
200440
200540
200610
200740
200820
200970
201070
201190
2012140
201340
201491
201550
201680
2017140
201890
201950
202090
202190
2022100
202380
202460
202570
202650
FIG. 1 — Lineage of K935425, 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (166)

See all 166

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

NumberDeviceApplicantDecidedDescendants
K991059Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018 Support…Spectranetics Corp.1999165
K022138Spectranetics 0.035 Support Catheter, Model 518-028Spectranetics Corp.2002108

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K141547Wingman Extendable Tip Support CatheterReflow Medical · 2014 · 6 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K991059 (Spectranetics Corp., 1999) has gone furthest, with 165 descendants of its own.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

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)—

More from Medtronics Interventional Vascular

66 FDA decisions under this applicant name. See the company

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  • K982883Medtronic 7F and 8F Zuma Guiding CatheterMedtronics Interventional Vascular · 199810 recalls
  • K981198Medtronic Zuma Guiding CatheterMedtronics Interventional Vascular · 199825 recalls

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https://510kreport.com/device/K935425 · printed Nov 6, 2026

Cite this page

510(k) Report. “K935425: Metronic Buchbinder Envoy Percutaneous Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935425

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026