510(k) · Cleared
ClearedEvt Angioscale Angiographic Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guidant Cardiac and Vascular Surgery · DQO Catheter, Intravascular, Diagnostic
Cleared on May 8, 1997 as substantially equivalent to K862006 (Cordis Corp., 1986) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- May 8, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K862006 (1986). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK862006 Stand & High Flow Femoral-Ventricular Pigtail CathCordis Corp. · 1986
- This deviceK970469 Evt Angioscale Angiographic CatheterGuidant Cardiac and Vascular Surgery · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K862006 | Stand & High Flow Femoral-Ventricular Pigtail Cath | Cordis Corp. | 1986 | — |
| 0 (this device) | K970469 | Evt Angioscale Angiographic Catheter | Guidant Cardiac and Vascular Surgery | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 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 DQO? 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 DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K862006 | Stand & High Flow Femoral-Ventricular Pigtail CathSummary page 1…stantial Equivalence: The EVT® AngioScale™ angiographic catheter is substantially equivalent to the Cordis Standard and High Flow Femoral-Ventricular Pigtail Catheters (K862006, Class II), the Cordis 5.2 French Super Torque Plus Cardiology Catheter (K914007, Class II), the Cordis Quanticor Marker Cathete… | 1986 |
| * | K914007 | Cordis 5.2 French Super Torque Plus Cardio CathSummary page 1…y equivalent to the Cordis Standard and High Flow Femoral-Ventricular Pigtail Catheters (K862006, Class II), the Cordis 5.2 French Super Torque Plus Cardiology Catheter (K914007, Class II), the Cordis Quanticor Marker Catheter (Class II), and the Cordis Ducor Angiographic Catheter (Class II). Device Desc… | 1991 |
| * | — | Cordis Quanticor Marker Catheter Named without a submission number | |
| * | — | Cordis Ducor Angiographic Catheter Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K862006.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, 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 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
What is it indicated for?
The EVT AngioScale angiography catheters provides angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system.
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/K970469 · printed Nov 5, 2026
Cite this page
510(k) Report. “K970469: Evt Angioscale Angiographic Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970469
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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