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 Apr 4, 1997 as substantially equivalent to K962510 (Heartport, Inc., 1996) and 1 other predicate after a 169-day review. Its family tree reaches back 1 generation to 1996. It has been recalled 4 times.
- Decided
- Apr 4, 1997
- Review
- 169 days
- Class
- Class II
- Product code
- DXC
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 1 generation to K955132 (1996). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK955132 Heartport Endoaortic ClampHeartport, Inc. · 1996 · Recalled
- This deviceK964161 Heartport Endoaortic ClampHeartport, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955132 | Heartport Endoaortic Clamp | Heartport, Inc. | 1996 | 2 |
| 0 (this device) | K964161 | Heartport Endoaortic Clamp | Heartport, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 |
|---|---|---|---|
| * | K962510 | Heartport Endoaortic ClampSummary page 1…ndoaortic Clamp™ Common Name: Endoaortic Clamp Catheter Classification Name: Cardiopulmonary bypass vascular catheter Equivalent Devices: Heartport Endoaortic Clamp - K962510 Heartport Endoaortic Clamp - K955132 Intended Use: Occlusion of the aorta, delivery of cardioplegic solution, and monitoring of… | 1996 |
| * | K955132 | Heartport Endoaortic ClampSummary page 1…rtic Clamp Catheter Classification Name: Cardiopulmonary bypass vascular catheter Equivalent Devices: Heartport Endoaortic Clamp - K962510 Heartport Endoaortic Clamp - K955132 Intended Use: Occlusion of the aorta, delivery of cardioplegic solution, and monitoring of aortic root pressure during cardiopul… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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. |
| Nov 26, 2008 | Not classified | Z-0644-2009 | Nonconforming Material/Component | Balloon rupture: Catheter balloon may rupture during cardiopulmonary bypass procedure. For further information, please telephone Edwards Lifesciences Research Medical, Inc. at 801-565-6173. |
| Nov 26, 2008 | Not classified | Z-0645-2009 | Nonconforming Material/Component | Balloon rupture: Catheter balloon may rupture during cardiopulmonary bypass procedure. For further information, please telephone Edwards Lifesciences Research Medical, Inc. at 801-565-6173. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 2 of the 2 ancestors have a recall of any class.
- 1 other device also cites its predicate K962510.
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 cardioplegic solution, 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/K964161 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964161: 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/K964161
Report an extraction error
Are you the manufacturer?
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