510(k) · Cleared
ClearedVIOLA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascular Graft Solutions, Ltd. · DXC Clamp, Vascular
Cleared on Feb 17, 2021 as substantially equivalent to K130382 (Boston Scientific Corporation, 2013) after a 100-day review. Its family tree reaches back 5 generations to 1980. 1 later device descends from it.
- Decided
- Feb 17, 2021
- Review
- 100 days
- Class
- Class II
- Product code
- DXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K800122 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK800122 Hancock Aortic PunchHancock Laboratories, Inc. · 1980
- 4 generations backK980128 Baladi Inverter with Coaxial Aortic PunchCardio Medical Solutions, Inc. · 1998
- 3 generations backK022880 Guidant Proximal Seal System, Models PSS-4500 & PS-4500Guidant Corp. · 2002 · Recalled
- 2 generations backK080169 Heartstring Iii Proximal Seal SystemGuidant Corporation, Cardiac Surgery · 2008
- 1 generation backK130382 Heartstring Iii Proximal Seal SystemBoston Scientific Corporation · 2013 · Recalled
- This deviceK203307 VIOLAVascular Graft Solutions, Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK230248 VIOLAVascular Graft Solutions, Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K230248VIOLAVascular Graft Solutions, Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K800122 | Hancock Aortic Punch | Hancock Laboratories, Inc. | 1980 | — |
| −4 | K980128 | Baladi Inverter with Coaxial Aortic Punch | Cardio Medical Solutions, Inc. | 1998 | — |
| −3 | K022880 | Guidant Proximal Seal System, Models PSS-4500 & PS-4500 | Guidant Corp. | 2002 | 1 |
| −2 | K080169 | Heartstring Iii Proximal Seal System | Guidant Corporation, Cardiac Surgery | 2008 | — |
| −1 | K130382 | Heartstring Iii Proximal Seal System | Boston Scientific Corporation | 2013 | 3 |
| 0 (this device) | K203307 | VIOLA | Vascular Graft Solutions, Ltd. | 2021 | — |
| +1 | K230248 | VIOLA | Vascular Graft Solutions, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 DXC? 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 DXC device
- #1 K262086 PreludeSYNC™ Radial Compression Devicescore 13.5 · 7 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 |
|---|---|---|---|
| * | K130382 | Heartstring Iii Proximal Seal SystemSummary page 4…ular Clamp Classification Name 21 CFR 870.4450, Class II, Product Code DXC Predicate Devices MAQUET Cardiovascular LLC’s HEARTSTRING III Proximal Seal (K130382) Intended Use / Indications for Use VIOLA clampless proximal anastomosis sealing system is indicated for use by cardiac… | 2013 |
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 |
|---|---|---|---|
| K230248 | VIOLA | 2023 | 0 |
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?
- The line of descent spans 41 years and passes through 6 companies; a new generation was cleared every 5.4 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K230248 (Vascular Graft Solutions, Ltd., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DXC devicesDXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · DXC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXC
215in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXC
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXC
442in 2025
MAUDE reports naming product code DXC, 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 | 10 | 52 | 0 | 298 |
| 2008 | 3 | 29 | 2 | 302 |
| 2009 | 4 | 83 | 2 | 539 |
| 2010 | 2 | — | 1 | 600 |
| 2011 | 6 | 51 | 3 | 691 |
| 2012 | 5 | 73 | 0 | 548 |
| 2013 | 14 | 89 | 0 | 920 |
| 2014 | 4 | 157 | 1 | 494 |
| 2015 | 5 | 71 | 0 | 374 |
| 2016 | 3 | 91 | 0 | 494 |
| 2017 | 3 | 90 | 0 | 416 |
| 2018 | 2 | — | 0 | 391 |
| 2019 | 2 | — | 0 | 393 |
| 2020 | 3 | 209 | 0 | 404 |
| 2021 | 6 | 37 | 0 | 371 |
| 2022 | 1 | — | 1 | 273 |
| 2023 | 4 | 215 | 2 | 674 |
| 2024 | 1 | — | 0 | 375 |
| 2025 | 2 | — | 0 | 442 |
| 2026 | 4 | 125 | 0 | — |
What is it indicated for?
VIOLA clampless proximal anastomosis sealing system is indicated for use by cardiac surgeons during coronary artery bypass grafting procedures to maintain hemostasis and facilitate the completion of proximal anastomoses to the aorta without application of an aortic clamp.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203307 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203307: VIOLA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203307
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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