PMA · Approved
Recalled · Class I · 2025Tack Endovascular System (6F)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Image Guided Therapy Corporation · QCT Scaffold, Dissection Repair
Approved on Apr 11, 2019 through premarket approval, which rests on the device’s own clinical evidence after a 223-day review. It has a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Apr 11, 2019
- Review
- 223 days
- Class
- Class III
- Product code
- QCT
- Recalls
- 1 (1 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P180034 has 7 supplements since 2020: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2020 | 3 |
| 2021 | 2 |
| 2022 | 2 |
Sources: FDA PMA database (decision fields and supplements), 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
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 |
|---|---|---|---|---|
| Jan 10, 2025 | Class I | Z-1070-2025 | Device Design | Use of Tack Endovascular system, designed to treat acute dissections of inner wall or lining of an artery by tacking damaged tissue to inner luminal surface, could result in problems with deployment and stability of device in vessel after… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All QCT devicesQCT Scaffold, Dissection Repair: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · QCT
5in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · QCT
Too few QCT 510(k)s in any year since 2007 to give a median.
Recalls per year · QCT
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · QCT
1in 2025
MAUDE reports naming product code QCT, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 5 | — | 0 | 3 |
| 2021 | 3 | — | 0 | 6 |
| 2022 | 5 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 464 |
| 2025 | 0 | — | 1 (1) | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P180034 · printed Nov 4, 2026
Cite this page
510(k) Report. “P180034: Tack Endovascular System (6F).” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/P180034
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026