510(k) Report

510(k) · Cleared

Cleared

Alviguide Blue+ Interventional Cardiology Guiding Catheter

K141529510(k) TraditionalCleared Dec 3, 2014177-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

Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S · DQY Catheter, Percutaneous

Cleared on Dec 3, 2014 as substantially equivalent to K062420 (Medtronic Vascular, 2006) and 4 other predicates after a 177-day review. Its family tree reaches back 6 generations to 1998. 1 of the 12 devices in its family, counting itself, has a Class I recall.

Decided
Dec 3, 2014
Review
177 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
5

Its longest line of descent runs back 6 generations to K981198 (1998). 11 ancestors in all. No later device cites it as a predicate yet. 1 of the 12 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 2005: 1 other ancestor2004: 2 other ancestors, 1 with a Class I recall12003: 1 other ancestor2001: 1 other ancestorK981198 · Medtronic Zuma Guiding Catheter · Medtronics Interventional Vascular · 1998 · recalledK021256 · Z3 Guide Catheter · Medtronic Vascular · 2002 · recalled×2: 2 generations cleared close together, K022764 (2002), K023402 (2002) K060418 · 8F Sherpa NX Guide Catheter · Medtronic Vascular · 2006K062420 · 5F Sherpa Active NX Guide Catheter · Medtronic Vascular · 200619952000200520102015
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors3 generations back: 1 other ancestor, 1 with a Class I recall1 K062420 · 5F Sherpa Active NX Guide Catheter · Medtronic Vascular · 2006K060418 · 8F Sherpa NX Guide Catheter · Medtronic Vascular · 2006K023402 · 8F Launcher Guide Catheter · Medtronic Vascular · 2002 · recalledK022764 · 7F Launcher Guide Catheter · Medtronic Vascular · 2002 · recalledK021256 · Z3 Guide Catheter · Medtronic Vascular · 2002 · recalledK981198 · Medtronic Zuma Guiding Catheter · Medtronics Interventional Vascular · 1998 · recalled−50
  1. Root · 6 generations backK981198 Medtronic Zuma Guiding CatheterMedtronics Interventional Vascular · 1998 · Recalled
  2. 5 generations backK021256 Z3 Guide CatheterMedtronic Vascular · 2002 · Recalled
  3. 4 generations backK022764 7F Launcher Guide CatheterMedtronic Vascular · 2002 · Recalled
  4. 3 generations backK023402 8F Launcher Guide CatheterMedtronic Vascular · 2002 · Recalled
  5. 2 generations backK060418 8F Sherpa NX Guide CatheterMedtronic Vascular · 2006
  6. 1 generation backK062420 5F Sherpa Active NX Guide CatheterMedtronic Vascular · 2006
  7. This deviceK141529 Alviguide Blue+ Interventional Cardiology Guiding CatheterAlvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S · 2014

Class I recalls in this family

  • K042489 6F Z4 Guide Catheter3 generations back · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K981198Medtronic Zuma Guiding CatheterMedtronics Interventional Vascular199825
−5K021256Z3 Guide CatheterMedtronic Vascular200252
−4K0227647F Launcher Guide CatheterMedtronic Vascular200213
−3K0234028F Launcher Guide CatheterMedtronic Vascular200218
−2K0604188F Sherpa NX Guide CatheterMedtronic Vascular2006—
−1K0624205F Sherpa Active NX Guide CatheterMedtronic Vascular2006—
0 (this device)K141529Alviguide Blue+ Interventional Cardiology Guiding CatheterAlvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200310
200421
200510
FIG. 1 — Lineage of K141529, 1998–2014Source: 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
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What was it cleared against? (7)

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
*K0624205F Sherpa Active NX Guide Catheter
Summary page 5
…K141529 510(k) SUMMARY PREDICATE DEVICES • Medtronic 5F Sherpa Active NX Guide Catheter (K062420) • Medtronic 6F Launcher Guide Catheter [Medtronic 6F Z3 Guide Catheter (K021256)] • Medtronic 7F Launcher Guide…
Medtronic Vascular2006—
*K021256Z3 Guide Catheter
Summary page 5
…ARY PREDICATE DEVICES • Medtronic 5F Sherpa Active NX Guide Catheter (K062420) • Medtronic 6F Launcher Guide Catheter [Medtronic 6F Z3 Guide Catheter (K021256)] • Medtronic 7F Launcher Guide Catheter (K022764) • Medtronic 8F Launcher Guide Catheter (K023402) • Merit Medica…
Medtronic Vascular200252
*K0227647F Launcher Guide Catheter
Summary page 5
…ve NX Guide Catheter (K062420) • Medtronic 6F Launcher Guide Catheter [Medtronic 6F Z3 Guide Catheter (K021256)] • Medtronic 7F Launcher Guide Catheter (K022764) • Medtronic 8F Launcher Guide Catheter (K023402) • Merit Medical Systems Concierge Guiding Catheter [VasCon LLC…
Medtronic Vascular200213
*K0234028F Launcher Guide Catheter
Summary page 5
…ncher Guide Catheter [Medtronic 6F Z3 Guide Catheter (K021256)] • Medtronic 7F Launcher Guide Catheter (K022764) • Medtronic 8F Launcher Guide Catheter (K023402) • Merit Medical Systems Concierge Guiding Catheter [VasCon LLC Polaris Guiding Catheter (K043387)] INDICATIONS FOR…
Medtronic Vascular200218
*K043387Vascon Polaris Guiding Catheter
Summary page 5
…eter (K022764) • Medtronic 8F Launcher Guide Catheter (K023402) • Merit Medical Systems Concierge Guiding Catheter [VasCon LLC Polaris Guiding Catheter (K043387)] INDICATIONS FOR USE The Alviguide™ Blue+ Interventional Cardiology Guiding Catheter is intended for use in the intravascular i…
Vascon, LLC2005—
*—Medtronic 6F Launcher Guide Catheter
Named without a submission number
—
*—Merit Medical Systems Concierge Guiding Catheter
Named without a submission number
—

Also cleared against K062420: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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.

  • K0424896F Z4 Guide CatheterMedtronic Vascular · 2004 · 3 generations back · ◆ in the 2004 ancestors bar of FIG. 1191 Class I recalls

What does this lineage say?

  • The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
  • 7 of the 11 ancestors have a recall of any class; 1 has a Class I recall.
  • 1 other device also cites its predicate K062420.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Alviguide™ Blue+ Interventional Cardiology Guiding Catheter is intended for use in the intravascular introduction of interventional/diagnostic devices into the coronary vascular system.

The Alguide™ Endovascular Guiding Catheter is intended for use in the intravascular introduction of interventional/diagnostic devices into the peripheral vascular system.

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

Also cleared against K062420

1 other device cites the same predicate.

  • K1326735F & 6F Launcher Guide Catheter, 5F Sherpa Active NX Guide Catheter, 6F Z4 Guiding CatheterMedtronic, Inc. · 2013191 Class I recalls

More from Alvimedica Tibbi Urunler Sanayi VE Dis…

2 FDA decisions under this applicant name. See the company

  • K143604Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic CathetersAlvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S · 2015

Recent decisions in DQY

The DQY category page

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https://510kreport.com/device/K141529 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141529: Alviguide Blue+ Interventional Cardiology Guiding Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141529

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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