510(k) · Cleared
ClearedVista Brite Tip 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 Jul 14, 1997 after a 75-day review. The FDA summary names its predicate without a number. 23 later devices descend from it.
- Decided
- Jul 14, 1997
- Review
- 75 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 0
23 later devices descend from it, 2 citing it directly.
- This deviceK971572 Vista Brite Tip CathetersCordis Corp. · 1997
- Descendant · cites it directly · 21 of its ownK071226 8FR Turbo Booster, Guide Catheter, 7FR Turbo Booster, Model 518-063…Spectranetics Corp. · 2007 · Recalled
- Descendant · 2 generations on · 20 of its ownK091299 Spectranetics Turbo-Tandem SystemSpectranetics Corp. · 2009
- Descendant · 3 generations on · 19 of its ownK094036 Turbo-Tandem System Model 472-110Spectranetics Corp. · 2010
- Descendant · 3 generations on · 17 of its ownK140775 Turbo-Elite Atherectomy Catheters, Turbo Tandem SystemSpectranetics Corporation · 2014 · Recalled
- Descendant · 4 generations on · 8 of its ownK181642 B-Laser Atherectomy SystemEximo Medical, Ltd. · 2018
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K0712268FR Turbo Booster, Guide Catheter, 7FR Turbo Booster, Model 518-063, 518-043Spectranetics Corp. · 2007 · cites it directly21descendants
- K091299Spectranetics Turbo-Tandem SystemSpectranetics Corp. · 2009 · 2 generations on20descendants
- K094036Turbo-Tandem System Model 472-110Spectranetics Corp. · 2010 · 3 generations on19descendants
- K140775Turbo-Elite Atherectomy Catheters, Turbo Tandem SystemSpectranetics Corporation · 2014 · 3 generations on17descendants
- K181642B-Laser Atherectomy SystemEximo Medical, Ltd. · 2018 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971572 | Vista Brite Tip Catheters | Cordis Corp. | 1997 | — |
| +1 | K071226 | 8FR Turbo Booster, Guide Catheter, 7FR Turbo Booster, Model 518-063, 518-043 | Spectranetics Corp. | 2007 | 2 |
| +2 | K091299 | Spectranetics Turbo-Tandem System | Spectranetics Corp. | 2009 | — |
| +3 | K094036 | Turbo-Tandem System Model 472-110 | Spectranetics Corp. | 2010 | — |
| +3 | K140775 | Turbo-Elite Atherectomy Catheters, Turbo Tandem System | Spectranetics Corporation | 2014 | 3 |
| +4 | K181642 | B-Laser Atherectomy System | Eximo Medical, Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (3)
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 Vista Brite Tip Named without a submission number | |
| * | — | Cordis Endovascular Systems, ENVOY Guiding Catheters Named without a submission number | |
| * | — | DVI, Devices for Vascular Intervention Named without a submission number |
What descends from it? (23)
See all 232 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, K071226 (Spectranetics Corp., 2007) has gone furthest, with 21 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?
The guiding cather is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary, peripheral, and neurovasculature.
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/K971572 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971572: Vista Brite Tip Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971572
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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