510(k) · Cleared
ClearedSolera Plus Thrombectomy Catheter, 55 CM and 110 CM, Models Bac SMG 007 055, Bac SMG 007 110
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bacchus Vascular, Inc. · MCW Catheter, Peripheral, Atherectomy
Cleared on Feb 4, 2004 as substantially equivalent to K003570 (Bacchus Vascular, Inc., 2001) and 1 other predicate after a 42-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Feb 4, 2004
- Review
- 42 days
- Class
- Class II
- Product code
- MCW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K003570 (2001). No later device cites it as a predicate yet.
- Root · 2 generations backK003570 Bacchus Thrombectomy Catheter (BTC), Model BTC-0755Bacchus Vascular, Inc. · 2001
- 1 generation backK022640 Solera Magnum Thrombectomy Catheter, 55 CM, Model Bac SMG 007 055 &…Bacchus Vascular, Inc. · 2002
- This deviceK033997 Solera Plus Thrombectomy Catheter, 55 CM and 110 CM, Models Bac SMG…Bacchus Vascular, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003570 | Bacchus Thrombectomy Catheter (BTC), Model BTC-0755 | Bacchus Vascular, Inc. | 2001 | — |
| −1 | K022640 | Solera Magnum Thrombectomy Catheter, 55 CM, Model Bac SMG 007 055 & Solera… | Bacchus Vascular, Inc. | 2002 | — |
| 0 (this device) | K033997 | Solera Plus Thrombectomy Catheter, 55 CM and 110 CM, Models Bac SMG 007 055… | Bacchus Vascular, Inc. | 2004 | — |
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? (2)
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 |
|---|---|---|---|
| * | K003570 | Bacchus Thrombectomy Catheter (BTC), Model BTC-0755Summary page 1…lus Thrombectomy Catheter permits mechanical thrombectomy of synthetic dialysis grafts. Predicate Devices Solera Thrombectomy Catheter K003570 Manufactured by Bacchus Vascular, Inc. Solera MagnumThrombectomy Catheter K022640 Manufactured by B… | 2001 |
| * | K022640 | Solera Magnum Thrombectomy Catheter, 55 CM, Model Bac SMG 007 055 & Solera Magnum…Summary page 1…lera Thrombectomy Catheter K003570 Manufactured by Bacchus Vascular, Inc. Solera MagnumThrombectomy Catheter K022640 Manufactured by Bacchus Vascular, Inc. Device Description The Solera Plus is a single-use, over-the-wire disposable catheter… | 2002 |
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.
What does this lineage say?
- The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 1.5 years on median.
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K003570.
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 Solera Plus Thrombectomy Catheter permits mechanical thrombectomy of synthetic dialysis grafts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033997 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033997: Solera Plus Thrombectomy Catheter, 55 CM and 110 CM, Models Bac SMG 007 055, Bac SMG 007 110.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033997
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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