510(k) · Cleared
Recalled · 2010Guidant Proximal Seal System, Models PSS-4500 & PS-4500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guidant Corp. · DXC Clamp, Vascular
Cleared on Sep 13, 2002 as substantially equivalent to K980128 (Cardio Medical Solutions, Inc., 1998) after a 14-day review. Its family tree reaches back 2 generations to 1980. 4 later devices descend from it. It has been recalled once.
- Decided
- Sep 13, 2002
- Review
- 14 days
- Class
- Class II
- Product code
- DXC
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K800122 (1980). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK800122 Hancock Aortic PunchHancock Laboratories, Inc. · 1980
- 1 generation backK980128 Baladi Inverter with Coaxial Aortic PunchCardio Medical Solutions, Inc. · 1998
- This deviceK022880 Guidant Proximal Seal System, Models PSS-4500 & PS-4500Guidant Corp. · 2002
- Descendant · cites it directly · 3 of its ownK080169 Heartstring Iii Proximal Seal SystemGuidant Corporation, Cardiac Surgery · 2008
- Descendant · 2 generations on · 2 of its ownK130382 Heartstring Iii Proximal Seal SystemBoston Scientific Corporation · 2013 · Recalled
- Descendant · 3 generations on · 1 of its ownK203307 VIOLAVascular Graft Solutions, Ltd. · 2021
- Descendant · 4 generations on · 0 of its ownK230248 VIOLAVascular Graft Solutions, Ltd. · 2023
Most influential descendants
Showing 4 of 4 · See all- K080169Heartstring Iii Proximal Seal SystemGuidant Corporation, Cardiac Surgery · 2008 · cites it directly3descendants
- K130382Heartstring Iii Proximal Seal SystemBoston Scientific Corporation · 2013 · 2 generations on2descendants
- K203307VIOLAVascular Graft Solutions, Ltd. · 2021 · 3 generations on1descendant
- K230248VIOLAVascular Graft Solutions, Ltd. · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K800122 | Hancock Aortic Punch | Hancock Laboratories, Inc. | 1980 | — |
| −1 | K980128 | Baladi Inverter with Coaxial Aortic Punch | Cardio Medical Solutions, Inc. | 1998 | — |
| 0 (this device) | K022880 | Guidant Proximal Seal System, Models PSS-4500 & PS-4500 | Guidant Corp. | 2002 | — |
| +1 | K080169 | Heartstring Iii Proximal Seal System | Guidant Corporation, Cardiac Surgery | 2008 | — |
| +2 | K130382 | Heartstring Iii Proximal Seal System | Boston Scientific Corporation | 2013 | 3 |
| +3 | K203307 | VIOLA | Vascular Graft Solutions, Ltd. | 2021 | — |
| +4 | K230248 | VIOLA | Vascular Graft Solutions, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K980128 | Baladi Inverter with Coaxial Aortic PunchSummary page 2…of an aortic clamp. G. Substantial Equivalence Guidant proposes that the Proximal Seal is similar to and substantially equivalent to the Baladi Inverter (K980128) and the Novare Enclose anastomotic assist devices. The subject device is substantially equivalent to the predicate dev… | 1998 |
| * | — | Novare Enclose anastomotic assist devices Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080169 | Heartstring Iii Proximal Seal System | 2008 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 5, 2010 | Not classified | Z-0940-2011 | Process design | Deployment tube may detach during use due to insufficient adhesive, which may result in product failure to operate. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 18.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K080169 (Guidant Corporation, Cardiac Surgery, 2008) has gone furthest, with 3 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.
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 Proximal Seal System is intended for use by cardiac surgeons during CABG procedures to maintain hemostasis and to facilitate the completion of a proximal anastomosis without application of an aortic clamp.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022880 · printed Nov 5, 2026
Cite this page
510(k) Report. “K022880: Guidant Proximal Seal System, Models PSS-4500 & PS-4500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022880
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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