510(k) · Cleared
ClearedEstech Arterial Remote Access Perfusion Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Estech, Inc. · DXC Clamp, Vascular
Cleared on Mar 11, 1999 after a 16-day review. The FDA summary names its predicate without a number. 2 of the 10 devices in its family, counting itself, have a Class I recall. 9 later devices descend from it.
- Decided
- Mar 11, 1999
- Review
- 16 days
- Class
- Class II
- Product code
- DXC
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 3 citing it directly. 2 of the 10 devices in this family, counting this one, have a Class I recall.
- This deviceK990573 Estech Arterial Remote Access Perfusion CannulaEstech, Inc. · 1999
- Descendant · cites it directly · 4 of its ownK032632 Remote Access Perfusion Cannula Left Axillary 21 FrenchEstech, Inc. · 2003
- Descendant · cites it directly · 3 of its ownK083111 Impella 5.0 Catheter FamilyAbiomed, Inc. · 2009 · Recalled
- Descendant · cites it directly · 3 of its ownK080700 Duoflo CatheterThermopeutix, Inc. · 2008
- Descendant · 2 generations on · 2 of its ownK102726 Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK112219 Tapas CatheterThermopeutix, Inc. · 2011
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 9 · See all- K032632Remote Access Perfusion Cannula Left Axillary 21 FrenchEstech, Inc. · 2003 · cites it directly4descendants
- K083111Impella 5.0 Catheter FamilyAbiomed, Inc. · 2009 · cites it directly3descendants
- K080700Duoflo CatheterThermopeutix, Inc. · 2008 · cites it directly3descendants
- K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 2 generations on2descendants
- K112219Tapas CatheterThermopeutix, Inc. · 2011 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990573 | Estech Arterial Remote Access Perfusion Cannula | Estech, Inc. | 1999 | — |
| +1 | K032632 | Remote Access Perfusion Cannula Left Axillary 21 French | Estech, Inc. | 2003 | — |
| +1 | K083111 | Impella 5.0 Catheter Family | Abiomed, Inc. | 2009 | 1 |
| +1 | K080700 | Duoflo Catheter | Thermopeutix, Inc. | 2008 | — |
| +2 | K102726 | Cardiohelp System | Maquet Cardiopulmonary, AG | 2011 | Class I |
| +2 | K112219 | Tapas Catheter | Thermopeutix, Inc. | 2011 | — |
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 | 2 | 1 |
| 2013 | 1 | 0 |
| 2014 | 2 | 1 |
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.
2 devices in this family have 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 |
|---|---|---|---|
| * | — | Heartport Arterial Perfusion System 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? (2 Class I)
No FDA recall names this 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.
What does this lineage say?
- Of its descendants, K032632 (Estech, Inc., 2003) has gone furthest, with 4 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 ESTECH Arterial Remote Access Perfusion Cannula is intended for use in arterial perfusion of the aorta, via a femoral artery, in cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass (CPB). The device may also be used to occlude the ascending aorta, deliver cardioplegia solution and vent the aortic root.
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/K990573 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990573: Estech Arterial Remote Access Perfusion Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990573
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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