510(k) · Cleared
ClearedGT Leggiero
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Medical Corp. · DQY Catheter, Percutaneous
Cleared on Jan 27, 1999 as substantially equivalent to K915414 (Terumo Medical Corp., 1992) after a 288-day review. Its family tree reaches back 1 generation to 1992. 14 later devices descend from it.
- Decided
- Jan 27, 1999
- Review
- 288 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K915414 (1992). 14 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK915414 Terumo Angiogtaphic CatheterTerumo Medical Corp. · 1992
- This deviceK981359 GT LeggieroTerumo Medical Corp. · 1999
- Descendant · cites it directly · 13 of its ownK033583 ProgreatTerumo Medical Corp. · 2003
- Descendant · 2 generations on · 3 of its ownK173430 SeQure® NF and SeQure® MicrocathetersAccurate Medical Therapeutics, Ltd. · 2018
- Descendant · 2 generations on · 3 of its ownK033913 ProgreatTerumo Medical Corp. · 2004
- Descendant · 3 generations on · 2 of its ownK202797 Drakon and Sequre MicrocathetersAccurate Medical Therapeutics, Ltd. · 2020
- Descendant · 3 generations on · 1 of its ownK203487 Drakon and Sequre MicrocathetersAccurate Medical Therapeutics, Ltd. · 2020
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K033583ProgreatTerumo Medical Corp. · 2003 · cites it directly13descendants
- K173430SeQure® NF and SeQure® MicrocathetersAccurate Medical Therapeutics, Ltd. · 2018 · 2 generations on3descendants
- K033913ProgreatTerumo Medical Corp. · 2004 · 2 generations on3descendants
- K202797Drakon and Sequre MicrocathetersAccurate Medical Therapeutics, Ltd. · 2020 · 3 generations on2descendants
- K203487Drakon and Sequre MicrocathetersAccurate Medical Therapeutics, Ltd. · 2020 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915414 | Terumo Angiogtaphic Catheter | Terumo Medical Corp. | 1992 | — |
| 0 (this device) | K981359 | GT Leggiero | Terumo Medical Corp. | 1999 | — |
| +1 | K033583 | Progreat | Terumo Medical Corp. | 2003 | — |
| +2 | K173430 | SeQure® NF and SeQure® Microcatheters | Accurate Medical Therapeutics, Ltd. | 2018 | — |
| +2 | K033913 | Progreat | Terumo Medical Corp. | 2004 | — |
| +3 | K202797 | Drakon and Sequre Microcatheters | Accurate Medical Therapeutics, Ltd. | 2020 | — |
| +3 | K203487 | Drakon and Sequre Microcatheters | Accurate Medical Therapeutics, Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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.
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 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 |
|---|---|---|---|
| * | K915414 | Terumo Angiogtaphic CatheterSummary page 1…tasis. The Catheter should not be used in cerebral vessels. ' Note: This is the same intended use as the Terumo Angiographic Catheter (SP Catheter) cleared under 510(k) K915414. DESCRIPTION The GT Leggiero™ Catheter is a muitilayer single-lumen catheter 100-150cm in length with a maximum injection press… | 1992 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033583 | Progreat | 2003 | 13 |
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?
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 GT Leggiero Catheter is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremities and all coronary vessels. The GT Leggiero Catheter is also intended for drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis. The Catheter should not be used in cerebral vessels.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981359 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981359: GT Leggiero.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981359
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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