510(k) · Cleared
Recalled · Class II · 2025Heartstring Iii Proximal Seal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · DXC Clamp, Vascular
Cleared on Jun 5, 2013 as substantially equivalent to K080169 (Guidant Corporation, Cardiac Surgery, 2008) after a 111-day review. Its family tree reaches back 4 generations to 1980. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Jun 5, 2013
- Review
- 111 days
- Class
- Class II
- Product code
- DXC
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 4 generations to K800122 (1980). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK800122 Hancock Aortic PunchHancock Laboratories, Inc. · 1980
- 3 generations backK980128 Baladi Inverter with Coaxial Aortic PunchCardio Medical Solutions, Inc. · 1998
- 2 generations backK022880 Guidant Proximal Seal System, Models PSS-4500 & PS-4500Guidant Corp. · 2002 · Recalled
- 1 generation backK080169 Heartstring Iii Proximal Seal SystemGuidant Corporation, Cardiac Surgery · 2008
- This deviceK130382 Heartstring Iii Proximal Seal SystemBoston Scientific Corporation · 2013
- Descendant · cites it directly · 1 of its ownK203307 VIOLAVascular Graft Solutions, Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK230248 VIOLAVascular Graft Solutions, Ltd. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K800122 | Hancock Aortic Punch | Hancock Laboratories, Inc. | 1980 | — |
| −3 | K980128 | Baladi Inverter with Coaxial Aortic Punch | Cardio Medical Solutions, Inc. | 1998 | — |
| −2 | K022880 | Guidant Proximal Seal System, Models PSS-4500 & PS-4500 | Guidant Corp. | 2002 | 1 |
| −1 | K080169 | Heartstring Iii Proximal Seal System | Guidant Corporation, Cardiac Surgery | 2008 | — |
| 0 (this device) | K130382 | Heartstring Iii Proximal Seal System | Boston Scientific Corporation | 2013 | — |
| +1 | K203307 | VIOLA | Vascular Graft Solutions, Ltd. | 2021 | — |
| +2 | K230248 | VIOLA | Vascular Graft Solutions, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K080169 | Heartstring Iii Proximal Seal SystemSummary page 1…I Proximal Seal System Vascular Clamp According to 21 CFR 870.4450 of the Federal Food, Drug and Cosmetic Act, the device classification is Class II, Product code DXC. K080169 HEARTSTRING III Proximal Seal System (SE: 8 Feb 2008) The HEARTSTRING III-Proximal Seal System is a device designed to enable th… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203307 | VIOLA | 2021 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 15, 2025 | Class II | Z-2588-2025 | Under Investigation by firm | Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis. |
| Aug 15, 2025 | Class II | Z-2587-2025 | Under Investigation by firm | Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis. |
| Aug 15, 2025 | Class II | Z-2586-2025 | Under Investigation by firm | Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 33 years and passes through 5 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K203307 (Vascular Graft Solutions, Ltd., 2021) has gone furthest, with 1 descendant 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. 2013, 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?
The HEARTSTRING III Proximal Seal System is intended for use by Physicians during CABG procedures to maintain hemostasis and to facilitate the completion of a proximal anastomosis to the aorta without application of an aortic clamp.
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/K130382 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130382: Heartstring Iii Proximal Seal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130382
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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