510(k) · Cleared
Recalled · 2009Heartport Endoaortic Clamp Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heartport, Inc. · DWZ Device, Biopsy, Endomyocardial
Cleared on Dec 16, 1997 after a 40-day review. The FDA summary names its predicate without a number. 1 of the 10 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 16, 1997
- Review
- 40 days
- Class
- Class II
- Product code
- DWZ
- Recalls
- 2
- Predicates
- 0
9 later devices descend from it, 3 citing it directly. 1 of the 10 devices in this family, counting this one, has a Class I recall.
- This deviceK974175 Heartport Endoaortic Clamp CatheterHeartport, Inc. · 1997
- Descendant · cites it directly · 6 of its ownK023914 Coaxia Flocontrol CatheterCoaxia, Inc. · 2003
- Descendant · 2 generations on · 3 of its ownK080700 Duoflo CatheterThermopeutix, Inc. · 2008
- Descendant · 3 generations on · 1 of its ownK112219 Tapas CatheterThermopeutix, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK090970 Flocontrol , Model 1028Coaxia, Inc. · 2009
- Descendant · 3 generations on · 0 of its ownK192786 Gatekeeper Balloon CatheterArch Catheter, LLC · 2020
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K113182 Edwards Lifesciences Intraclude Intra-Aortic…cites it directly · 2011
Most influential descendants
Showing 5 of 9 · See all- K023914Coaxia Flocontrol CatheterCoaxia, Inc. · 2003 · cites it directly6descendants
- K080700Duoflo CatheterThermopeutix, Inc. · 2008 · 2 generations on3descendants
- K112219Tapas CatheterThermopeutix, Inc. · 2011 · 3 generations on1descendant
- K090970Flocontrol , Model 1028Coaxia, Inc. · 2009 · 2 generations on1descendant
- K192786Gatekeeper Balloon CatheterArch Catheter, LLC · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974175 | Heartport Endoaortic Clamp Catheter | Heartport, Inc. | 1997 | — |
| +1 | K023914 | Coaxia Flocontrol Catheter | Coaxia, Inc. | 2003 | — |
| +2 | K080700 | Duoflo Catheter | Thermopeutix, Inc. | 2008 | — |
| +3 | K112219 | Tapas Catheter | Thermopeutix, Inc. | 2011 | — |
| +2 | K090970 | Flocontrol , Model 1028 | Coaxia, Inc. | 2009 | — |
| +3 | K192786 | Gatekeeper Balloon Catheter | Arch Catheter, LLC | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 1 |
| 2014 | 1 | 0 |
| 2020 | 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.
1 device in this family has a Class I recall. 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 DWZ device
- #1 K252722 Biopsy Forcepsscore 10.7 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | — | Heartport® Endoaortic Clamp™ catheter Named without a submission number | |
| * | — | Medi-tech Occlusion Balloon catheter Named without a submission number |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 24, 2009 | Not classified | Z-0085-2010 | Process control | Spontaneous balloon rupture during use of the product. |
| Apr 12, 2005 | Not classified | Z-0811-05 | Other | Guidewire is protruding through the film portion of the packages which compromises the sterility of the device. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K113182Edwards Lifesciences Intraclude Intra-Aortic CatheterEdwards Lifesciences, LLC · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K023914 (Coaxia, Inc., 2003) has gone furthest, with 6 descendants of its own.
How does its category compare?
All DWZ devicesDWZ Device, Biopsy, Endomyocardial: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DWZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DWZ
Too few DWZ 510(k)s in any year since 2007 to give a median.
Recalls per year · DWZ
No recall names DWZ since 2007.
Adverse event reports per year · DWZ
1in 2025
MAUDE reports naming product code DWZ, 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 | 1 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 14 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Heartport Endoaortic Clamp catheter is indicated for use in patients undergoing cardiopulmonary bypass. The Endoaortic Clamp catheter occludes and vents the ascending aorta when the balloon is inflated. The device’s central lumen allows delivery of cardioplegia to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure.
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/K974175 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974175: Heartport Endoaortic Clamp Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974175
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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