510(k) · Cleared
ClearedHeart Technology Rotablator Wireclip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heart Technology, Inc. · MCW Catheter, Peripheral, Atherectomy
Cleared on Sep 6, 1991 after a 35-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Sep 6, 1991
- Review
- 35 days
- Class
- Class II
- Product code
- MCW
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK913450 Heart Technology Rotablator WireclipHeart Technology, Inc. · 1991
- Descendant · cites it directly · 2 of its ownK121774 Rotablator Rotational Atherectomy System with Peripheral Rotalink PlusBoston Scientific Corp · 2012
- Descendant · 2 generations on · 1 of its ownK133566 Rotablator Rotational Atherectomy System with the Peripheral…Boston Scientific Corp · 2013
- Descendant · 3 generations on · 0 of its ownK220962 ROTAPRO Rotational Atherectomy SystemBoston Scientific Corporation · 2022
Most influential descendants
Showing 3 of 3 · See all- K121774Rotablator Rotational Atherectomy System with Peripheral Rotalink PlusBoston Scientific Corp · 2012 · cites it directly2descendants
- K133566Rotablator Rotational Atherectomy System with the Peripheral Rotalink PlusBoston Scientific Corp · 2013 · 2 generations on1descendant
- K220962ROTAPRO Rotational Atherectomy SystemBoston Scientific Corporation · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K913450 | Heart Technology Rotablator Wireclip | Heart Technology, Inc. | 1991 | — |
| +1 | K121774 | Rotablator Rotational Atherectomy System with Peripheral Rotalink Plus | Boston Scientific Corp | 2012 | — |
| +2 | K133566 | Rotablator Rotational Atherectomy System with the Peripheral Rotalink Plus | Boston Scientific Corp | 2013 | — |
| +3 | K220962 | ROTAPRO Rotational Atherectomy System | Boston Scientific Corporation | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MCW? 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 MCW device
- #1 K233668 Auryon Atherectomy Catheter 1.5 mm XL…score 17.6 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121774 | Rotablator Rotational Atherectomy System with Peripheral Rotalink Plus | 2012 | 2 |
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.
What does this lineage say?
- Of its descendants, K121774 (Boston Scientific Corp, 2012) has gone furthest, with 2 descendants of its own.
How does its category compare?
All MCW devicesMCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MCW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MCW
46in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MCW
2in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · MCW
677in 2025
MAUDE reports naming product code MCW, 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 | 5 | 43 | 2 | 50 |
| 2008 | 6 | 33 | 1 | 115 |
| 2009 | 8 | 27 | 3 | 105 |
| 2010 | 6 | 30 | 1 | 167 |
| 2011 | 6 | 39 | 0 | 204 |
| 2012 | 5 | 29 | 0 | 194 |
| 2013 | 5 | 30 | 0 | 134 |
| 2014 | 7 | 117 | 0 | 210 |
| 2015 | 6 | 30 | 0 | 377 |
| 2016 | 5 | 60 | 2 | 409 |
| 2017 | 7 | 91 | 2 | 415 |
| 2018 | 8 | 103 | 0 | 537 |
| 2019 | 3 | 112 | 0 | 618 |
| 2020 | 2 | — | 0 | 631 |
| 2021 | 6 | 119 | 2 (2) | 734 |
| 2022 | 6 | 69 | 2 (2) | 566 |
| 2023 | 4 | 104 | 1 | 574 |
| 2024 | 3 | 41 | 2 | 677 |
| 2025 | 3 | 46 | 0 | 677 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K913450 · printed Nov 6, 2026
Cite this page
510(k) Report. “K913450: Heart Technology Rotablator Wireclip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913450
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026