510(k) Report

510(k) · Cleared

Cleared

LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension

K220691510(k) TraditionalCleared May 5, 202257-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

Seigla Medical, Inc. · DQY Catheter, Percutaneous

Cleared on May 5, 2022 as substantially equivalent to K172090 (Vascular Solutions, Inc., 2017) after a 57-day review. Its family tree reaches back 9 generations to 1994. 1 of the 17 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.

Decided
May 5, 2022
Review
57 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
1

Its longest line of descent runs back 9 generations to K935425 (1994). 15 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 17 devices in this family, counting this one, has a Class I recall.

  1. Root · 9 generations backK935425 Metronic Buchbinder Envoy Percutaneous CathetersMedtronics Interventional Vascular · 1994
  2. 5 generations between
  3. 3 generations backK091750 Guideliner Catheter, Models 5571, 5572, 5573Vascular Solutions, Inc. · 2009
  4. 2 generations backK112082 Guideliner V2 CatheterVascular Solutions, Inc. · 2011 · Recalled
  5. 1 generation backK172090 GuideLiner V3 CatheterVascular Solutions, Inc. · 2017
  6. This deviceK220691 LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter…Seigla Medical, Inc. · 2022
  7. Descendant · cites it directly · 0 of its ownK243691 LiquID .051 LP Guide Catheter ExtensionSeigla Medical, Inc. · 2025
Show all 9 generations
  1. Root · 9 generations backK935425 Metronic Buchbinder Envoy Percutaneous CathetersMedtronics Interventional Vascular · 1994
  2. 8 generations backK991059 Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics…Spectranetics Corp. · 1999
  3. 7 generations backK022138 Spectranetics 0.035 Support Catheter, Model 518-028Spectranetics Corp. · 2002
  4. 6 generations backK033678 Spectranetics Quick Cross Catheters, Models 518-032, 518-033…Spectranetics Corp. · 2004
  5. 5 generations backK052258 Vascular Solutions Skyway Support CatheterVascular Solutions, Inc. · 2005
  6. 4 generations backK082337 Minnie Support CatheterVascular Solutions, Inc. · 2009
  7. 3 generations backK091750 Guideliner Catheter, Models 5571, 5572, 5573Vascular Solutions, Inc. · 2009
  8. 2 generations backK112082 Guideliner V2 CatheterVascular Solutions, Inc. · 2011 · Recalled
  9. 1 generation backK172090 GuideLiner V3 CatheterVascular Solutions, Inc. · 2017
  10. This deviceK220691 LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter…Seigla Medical, Inc. · 2022

Class I recalls in this family

Most influential descendants

Showing 1 of 1 · See all
  • K243691LiquID .051 LP Guide Catheter ExtensionSeigla Medical, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K935425Metronic Buchbinder Envoy Percutaneous CathetersMedtronics Interventional Vascular1994—
−8K991059Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018…Spectranetics Corp.1999—
−7K022138Spectranetics 0.035 Support Catheter, Model 518-028Spectranetics Corp.2002—
−6K033678Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035…Spectranetics Corp.2004—
−5K052258Vascular Solutions Skyway Support CatheterVascular Solutions, Inc.2005—
−4K082337Minnie Support CatheterVascular Solutions, Inc.2009—
−3K091750Guideliner Catheter, Models 5571, 5572, 5573Vascular Solutions, Inc.2009—
−2K112082Guideliner V2 CatheterVascular Solutions, Inc.20111
−1K172090GuideLiner V3 CatheterVascular Solutions, Inc.2017—
0 (this device)K220691LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter ExtensionSeigla Medical, Inc.2022—
+1K243691LiquID .051 LP Guide Catheter ExtensionSeigla Medical, Inc.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200030
200210
200611
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202510
FIG. 1 — Lineage of K220691, 1994–2025Source: 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.

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
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
*K172090GuideLiner V3 Catheter
Summary page 4
…d Guide Catheter Extension is substantially equivalent in intended use, method of operation and technical aspects to the following predicate devices: Primary Predicate: K172090 - Vascular Solutions/Teleflex Guideliner V3 Catheters Additional Reference Devices: K163314 - Boston Scientific Guidezilla II Gu…
Vascular Solutions, Inc.2017—
†K163314Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension CatheterBoston Scientific Corporation20171
†K183353Telescope Guide Extension CatheterMedtronic, Inc.2019—
†K160561Boosting CatheterQxmedical, LLC2016—

Also cleared against K172090: 2 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K243691LiquID .051 LP Guide Catheter ExtensionSeigla Medical, Inc.20250

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.

  • K060327Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support CatheterVascular Solutions, Inc. · 2006 · 5 generations back · ◆ in the 2006 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
  • 2 of the 15 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K243691 (Seigla Medical, Inc., 2025) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K172090.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?

The LiqulD Guide Catheter Extension is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.

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

Cite this page

510(k) Report. “K220691: LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K220691

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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