510(k) · Cleared
Recalled · 2009Heartport Endoaortic Clamp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heartport, Inc. · DXC Clamp, Vascular
Cleared on Jun 7, 1996 after a 211-day review. The FDA summary names its predicate without a number. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 7, 1996
- Review
- 211 days
- Class
- Class II
- Product code
- DXC
- Recalls
- 2
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK955132 Heartport Endoaortic ClampHeartport, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK033085 PortaclampCardio Life Research, S.A. · 2004
- Descendant · 2 generations on · 0 of its ownK070380 Portaclamp FlexCardio Life Research, S.A. · 2007
- Descendant · cites it directly · 0 of its ownK964161 Heartport Endoaortic ClampHeartport, Inc. · 1997 · Recalled
- Descendant · cites it directly · 0 of its ownK962858 Heartport Endovascular Cardiopulmonary Bypass System Antegrade Sytem…Heartport, Inc. · 1996
Most influential descendants
Showing 4 of 4 · See all- K033085PortaclampCardio Life Research, S.A. · 2004 · cites it directly1descendant
- K070380Portaclamp FlexCardio Life Research, S.A. · 2007 · 2 generations on0descendants
- K964161Heartport Endoaortic ClampHeartport, Inc. · 1997 · cites it directly0descendants
- K962858Heartport Endovascular Cardiopulmonary Bypass System Antegrade Sytem (Catalog Number…Heartport, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955132 | Heartport Endoaortic Clamp | Heartport, Inc. | 1996 | — |
| +1 | K033085 | Portaclamp | Cardio Life Research, S.A. | 2004 | — |
| +2 | K070380 | Portaclamp Flex | Cardio Life Research, S.A. | 2007 | — |
| +1 | K964161 | Heartport Endoaortic Clamp | Heartport, Inc. | 1997 | 4 |
| +1 | K962858 | Heartport Endovascular Cardiopulmonary Bypass System Antegrade Sytem (Catalog… | Heartport, Inc. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 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? (6)
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 |
|---|---|---|---|
| * | — | Medi-tech Occlusion Balloon Catheter Named without a submission number | |
| * | — | RMI Coronary Sinus Perfusion & Pressure Monitoring Cannulae Named without a submission number | |
| * | — | Cooley Aortic Clamp Named without a submission number | |
| * | — | DLP Cardioplegia Pressure Cannula with Vent Line Named without a submission number | |
| * | — | Datascope PERCLUDER™ - DL Occluding Balloon Named without a submission number | |
| * | — | Fogarty Occluding Catheter Named without a submission number |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 24, 2009 | Not classified | Z-0084-2010 | Process control | Balloon catheters were spontaneously rupturing during use. |
| Sep 24, 2009 | Not classified | Z-0085-2010 | Process control | Spontaneous balloon rupture during use of the product. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K033085 (Cardio Life Research, S.A., 2004) 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.
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?
Occlusion of the aorta, delivery of cardioplegia, and monitoring of aortic root
pressure during cardiopulmonary bypass.
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/K955132 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955132: Heartport Endoaortic Clamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955132
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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