510(k) · Cleared
ClearedRotablator System's Guide Wire Line: Support Rotawire Rail Rota Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heart Technology Mfg., Inc. · MCW Catheter, Peripheral, Atherectomy
Cleared on Apr 25, 1996 after a 90-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Apr 25, 1996
- Review
- 90 days
- Class
- Class II
- Product code
- MCW
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK960379 Rotablator System's Guide Wire Line: Support Rotawire Rail Rota WireHeart Technology Mfg., Inc. · 1996
- 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) | K960379 | Rotablator System's Guide Wire Line: Support Rotawire Rail Rota Wire | Heart Technology Mfg., Inc. | 1996 | — |
| +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), 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.
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? (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 |
|---|---|---|---|
| * | — | Type C guide wire Named without a submission number |
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 | — |
What is it indicated for?
The Rotablator system is intended for percutaneous use in peripheral vessels in patients with occlusive atherosclerotic disease who are acceptable candidates for bypass graft surgery or percutaneous transluminal angioplasty.
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/K960379 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960379: Rotablator System's Guide Wire Line: Support Rotawire Rail Rota Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960379
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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