510(k) · Cleared
ClearedCordis Envoy & Vista Brite Tip Guiding Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Corp. · DQY Catheter, Percutaneous
Cleared on Aug 8, 1996 after a 50-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Aug 8, 1996
- Review
- 50 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK962362 Cordis Envoy & Vista Brite Tip Guiding CathetersCordis Corp. · 1996
- Descendant · cites it directly · 2 of its ownK141981 Asahi Fubuki 043 / Asahi FubukiAsahi Intecc Co., Ltd. · 2015
- Descendant · 2 generations on · 1 of its ownK213589 FUBUKI XF Neurovascular Long SheathAsahi Intecc Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK971646 4F Nylex Angiography Catheter/5F Nylex Angiography CatheterCordis Corp. · 1997
- Descendant · 3 generations on · 0 of its ownK251560 FUBUKI XF-R Neurovascular Long SheathAsahi Intecc Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK181836 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography…Cordis, A Cardinal Health Company · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K141981Asahi Fubuki 043 / Asahi FubukiAsahi Intecc Co., Ltd. · 2015 · cites it directly2descendants
- K213589FUBUKI XF Neurovascular Long SheathAsahi Intecc Co., Ltd. · 2022 · 2 generations on1descendant
- K9716464F Nylex Angiography Catheter/5F Nylex Angiography CatheterCordis Corp. · 1997 · cites it directly1descendant
- K251560FUBUKI XF-R Neurovascular Long SheathAsahi Intecc Co., Ltd. · 2025 · 3 generations on0descendants
- K1818364F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo…Cordis, A Cardinal Health Company · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962362 | Cordis Envoy & Vista Brite Tip Guiding Catheters | Cordis Corp. | 1996 | — |
| +1 | K141981 | Asahi Fubuki 043 / Asahi Fubuki | Asahi Intecc Co., Ltd. | 2015 | — |
| +2 | K213589 | FUBUKI XF Neurovascular Long Sheath | Asahi Intecc Co., Ltd. | 2022 | — |
| +1 | K971646 | 4F Nylex Angiography Catheter/5F Nylex Angiography Catheter | Cordis Corp. | 1997 | — |
| +3 | K251560 | FUBUKI XF-R Neurovascular Long Sheath | Asahi Intecc Co., Ltd. | 2025 | — |
| +2 | K181836 | 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F &… | Cordis, A Cardinal Health Company | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | — | Cordis ENVOY Named without a submission number | |
| * | — | Cordis Vista Brite Tip Named without a submission number |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K141981 (Asahi Intecc Co., Ltd., 2015) has gone furthest, with 2 descendants of its own.
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?
Vista Brite Tip: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary and peripheral vascular systems.
ENVOY: The ENVOY Guiding Catheter is intended for use in the peripheral, coronary and neurovasculature for the intravascular introduction of interventional/diagnostic devices.
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/K962362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962362: Cordis Envoy & Vista Brite Tip Guiding Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962362
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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