510(k) · Cleared
Recalled · Class I · 2019Edwards Lifesciences Intraclude Intra-Aortic Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences, LLC · DXC Clamp, Vascular
Cleared on Dec 7, 2011 as substantially equivalent to K974175 (Heartport, Inc., 1997) after a 40-day review. Its family tree reaches back 1 generation to 1997. 1 of the 2 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Dec 7, 2011
- Review
- 40 days
- Class
- Class II
- Product code
- DXC
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974175 (1997). No later device cites it as a predicate yet. 1 of the 2 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK974175 Heartport Endoaortic Clamp CatheterHeartport, Inc. · 1997 · Recalled
- This deviceK113182 Edwards Lifesciences Intraclude Intra-Aortic CatheterEdwards Lifesciences, LLC · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974175 | Heartport Endoaortic Clamp Catheter | Heartport, Inc. | 1997 | 2 |
| 0 (this device) | K113182 | Edwards Lifesciences Intraclude Intra-Aortic Catheter | Edwards Lifesciences, LLC | 2011 | — |
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 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 |
|---|---|---|---|
| * | K974175 | Heartport Endoaortic Clamp CatheterSummary page 1…assification Name: Vascular Clamp 21 CFR Part 870.4450, Product Code DXC, Class 11 Predicate Device: K974175: Heartport Endloaortic Clamp Catheter Device Description: The IntraClude lntra-Aortic Occlusion Device is a 9 Fr (3mm), triple-… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 14, 2019 | Class I | Z-1705-2019 | Device Design | Possibility of balloon rupture in intra-aortic occlusion devices. If the balloon bursts during cardiopulmonary bypass, the heart can fill and warm, the operative site may be obscured, and the device will need to be exchanged or operative… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 2 other devices also cite its predicate K974175.
How does its category compare?
All DXC devicesDXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 IntraClude Intra-Aortic Occlusion Catheter is indicated for use in patients undergoing cardiopulmonary bypass. The IntraClude Intra-Aortic Occlusion 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 as stated in the FDA summary.
https://510kreport.com/device/K113182 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113182: Edwards Lifesciences Intraclude Intra-Aortic Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113182
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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