510(k) · Cleared
Recalled · Class I · 20176F Taiga Guiding Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · DQY Catheter, Percutaneous
Cleared on Feb 6, 2009 as substantially equivalent to K042489 (Medtronic Vascular, 2004) after a 79-day review. Its family tree reaches back 3 generations to 1998. 2 of the 6 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled once, including a Class I recall.
- Decided
- Feb 6, 2009
- Review
- 79 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 3 generations to K981198 (1998). 4 ancestors in all. 1 later device descends from it, 1 citing it directly. 2 of the 6 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK981198 Medtronic Zuma Guiding CatheterMedtronics Interventional Vascular · 1998 · Recalled
- 2 generations backK021256 Z3 Guide CatheterMedtronic Vascular · 2002 · Recalled
- 1 generation backK042489 6F Z4 Guide CatheterMedtronic Vascular · 2004 · Recalled (Class I)
- This deviceK083422 6F Taiga Guiding CatheterMedtronic Vascular · 2009
- Descendant · cites it directly · 0 of its ownK192296 Medtronic 6F Taiga Guiding CatheterMedtronic Vascular · 2019
Class I recalls in this family
- K042489 6F Z4 Guide Catheterdirect predicate · 2004
Most influential descendants
Showing 1 of 1 · See all- K192296Medtronic 6F Taiga Guiding CatheterMedtronic Vascular · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K981198 | Medtronic Zuma Guiding Catheter | Medtronics Interventional Vascular | 1998 | 25 |
| −2 | K021256 | Z3 Guide Catheter | Medtronic Vascular | 2002 | 52 |
| −1 | K042489 | 6F Z4 Guide Catheter | Medtronic Vascular | 2004 | Class I |
| 0 (this device) | K083422 | 6F Taiga Guiding Catheter | Medtronic Vascular | 2009 | — |
| +1 | K192296 | Medtronic 6F Taiga Guiding Catheter | Medtronic Vascular | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
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.
2 devices in this family have 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 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042489 | 6F Z4 Guide CatheterSummary page 1…uiding Catheter Common Name: Guiding Catheter Classification Percutaneous Catheter Name: Predicate Device: Medtronic 6F Sherpa NX (Z4) Guiding Catheter, K042489 Device The 6F Taiga TM Guiding Catheter is a single lumen catheter Description: with an atraumatic tip, whic… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192296 | Medtronic 6F Taiga Guiding Catheter | 2019 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 26, 2017 | Class I | Z-1207-2018 | Nonconforming Material/Component | Complaints regarding 6F Taiga guide catheter tip detachment and/or tip splitting. |
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 · Direct predicate · ◆ on the line of descent in FIG. 1191 Class I recalls
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
- 4 of the 4 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K192296 (Medtronic Vascular, 2019) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K042489.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083422 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083422: 6F Taiga Guiding Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083422
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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