510(k) · Cleared
ClearedUrsa Angiographic Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Curative Medical Technology, Inc. · DQO Catheter, Intravascular, Diagnostic
Cleared on Jan 29, 2010 as substantially equivalent to K970854 (Cordis Corp., 1997) and 1 other predicate after a 344-day review. Its family tree reaches back 3 generations to 1992. 1 of the 7 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Jan 29, 2010
- Review
- 344 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K921310 (1992). 5 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 7 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK921310 Cordis 6 French Paragon Angiographic CatheterCordis Corp. · 1992
- 2 generations backK960975 1-4F Infiniti Angiographic CatheterCordis Corp. · 1996 · Recalled
- 1 generation backK970854 5 FR and 6 FR Infiniti Angiographic CatheterCordis Corp. · 1997 · Recalled (Class I)
- This deviceK090427 Ursa Angiographic CatheterCurative Medical Technology, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK123818 Ursa Angiographic CatheterCurative Medical Technology, Inc. · 2013
Class I recalls in this family
- K970854 5 FR and 6 FR Infiniti Angiographic Catheterdirect predicate · 1997
Most influential descendants
Showing 1 of 1 · See all- K123818Ursa Angiographic CatheterCurative Medical Technology, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921310 | Cordis 6 French Paragon Angiographic Catheter | Cordis Corp. | 1992 | — |
| −2 | K960975 | 1-4F Infiniti Angiographic Catheter | Cordis Corp. | 1996 | 1 |
| −1 | K970854 | 5 FR and 6 FR Infiniti Angiographic Catheter | Cordis Corp. | 1997 | Class I |
| 0 (this device) | K090427 | Ursa Angiographic Catheter | Curative Medical Technology, Inc. | 2010 | — |
| +1 | K123818 | Ursa Angiographic Catheter | Curative Medical Technology, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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.
1 device in this family has 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 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? (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 |
|---|---|---|---|
| * | K970854 | 5 FR and 6 FR Infiniti Angiographic CatheterSummary page 1…21 CFR 870.1200 Predicate Device: Infiniti Angiographic Catheter manufactured by Cordis, K970854 (September 30, 1997). Jogiraphy Angiographic Catheter manufactured by… | 1997 |
| * | K000825 | 4F-7F Medi-Dyne Torq Flow XLB Angiographic CatheterSummary page 1…Cordis, K970854 (September 30, 1997). Jogiraphy Angiographic Catheter manufactured by Abbott, K000825 (September 21, 2000) Device Description: The UrsaTrm angiographic catheters are sterile, single use, disposable devices design… | 2000 |
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 |
|---|---|---|---|
| K123818 | Ursa Angiographic Catheter | 2013 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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.
- K9708545 FR and 6 FR Infiniti Angiographic CatheterCordis Corp. · 1997 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- 3 of the 5 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K123818 (Curative Medical Technology, Inc., 2013) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K970854.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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 UrsaTm angiographic catheter is intended for use in the delivery of radiopaque contrast media to selected sites in the coronary and peripheral vasculature. The device is for single use only.
This device is not intended for use in the neurovasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090427 · printed Nov 5, 2026
Cite this page
510(k) Report. “K090427: Ursa 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/K090427
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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