PMA · Approved
ApprovedIvt Coronary Atherectomy System (Tec)(R)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intensive Technology, Inc. · MCX Catheter, Coronary, Atherectomy
Approved on May 18, 1993 through premarket approval, which rests on the device’s own clinical evidence after a 781-day review.
- Decided
- May 18, 1993
- Review
- 781 days
- Class
- Class III
- Product code
- MCX
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P910019 has 5 supplements since 1995: 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 |
|---|---|
| 1995 | 1 |
| 1996 | 1 |
| 1998 | 3 |
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.
Planning a device in MCX? 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? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All MCX devicesMCX Catheter, Coronary, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MCX
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MCX
Too few MCX 510(k)s in any year since 2007 to give a median.
Recalls per year · MCX
2in 2022
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · MCX
864in 2025
MAUDE reports naming product code MCX, 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 | 8 | — | 2 | 107 |
| 2008 | 8 | — | 0 | 185 |
| 2009 | 10 | — | 0 | 289 |
| 2010 | 5 | — | 0 | 319 |
| 2011 | 12 | — | 0 | 333 |
| 2012 | 10 | — | 0 | 293 |
| 2013 | 13 | — | 0 | 355 |
| 2014 | 18 | — | 0 | 412 |
| 2015 | 25 | — | 2 (2) | 629 |
| 2016 | 16 | — | 0 | 713 |
| 2017 | 23 | — | 0 | 735 |
| 2018 | 13 | — | 0 | 876 |
| 2019 | 15 | — | 1 | 788 |
| 2020 | 20 | — | 0 | 822 |
| 2021 | 9 | — | 1 | 901 |
| 2022 | 12 | — | 2 | 720 |
| 2023 | 18 | — | 0 | 706 |
| 2024 | 9 | — | 0 | 798 |
| 2025 | 10 | — | 0 | 864 |
| 2026 | 10 | — | 0 | — |
https://510kreport.com/device/P910019 · printed Nov 5, 2026
Cite this page
510(k) Report. “P910019: Ivt Coronary Atherectomy System (Tec)(R).” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/P910019
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026