510(k) · Cleared
ClearedSymmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Jul 24, 2015 as substantially equivalent to K060959 (Boston Scientific Corporation, 2006) after a 260-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Jul 24, 2015
- Review
- 260 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K953602 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK953602 Symmetry Small Vessel Balloon Dilatation CatheterBoston Scientific Corp · 1995
- 1 generation backK060959 Symmetry Balloon Dilatation CatheterBoston Scientific Corporation · 2006
- This deviceK143193 Symmetry and Symmetry Stiff Shaft Balloon Dilatation CathetersBoston Scientific · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953602 | Symmetry Small Vessel Balloon Dilatation Catheter | Boston Scientific Corp | 1995 | — |
| −1 | K060959 | Symmetry Balloon Dilatation Catheter | Boston Scientific Corporation | 2006 | — |
| 0 (this device) | K143193 | Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters | Boston Scientific | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 LIT? 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 LIT device
- #1 K241040 Amethyst HP PTA OTW 0.035 Catheterscore 13.9 · 9 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 |
|---|---|---|---|
| * | K060959 | Symmetry Balloon Dilatation CatheterSummary page 4…& Technology Park Tullamore, County Offaly, Ireland Predicate Devices Symmetry Balloon Dilatation Catheter K060959 cleared April 12, 2006.… | 2006 |
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 20 years and passes through 3 companies; a new generation was cleared every 10.5 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · LIT
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LIT
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LIT
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LIT
2,073in 2025
MAUDE reports naming product code LIT, 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 | 6 | 64 | 0 | 577 |
| 2008 | 8 | 53 | 0 | 513 |
| 2009 | 7 | 29 | 2 | 623 |
| 2010 | 13 | 78 | 1 | 809 |
| 2011 | 10 | 82 | 0 | 857 |
| 2012 | 19 | 29 | 0 | 1,277 |
| 2013 | 14 | 79 | 2 (2) | 1,242 |
| 2014 | 12 | 90 | 3 | 1,178 |
| 2015 | 19 | 112 | 0 | 1,279 |
| 2016 | 11 | 116 | 1 | 1,529 |
| 2017 | 9 | 57 | 0 | 2,081 |
| 2018 | 6 | 118 | 2 | 2,188 |
| 2019 | 4 | 40 | 3 | 2,405 |
| 2020 | 9 | 125 | 0 | 2,443 |
| 2021 | 4 | 61 | 1 | 2,492 |
| 2022 | 8 | 122 | 0 | 2,155 |
| 2023 | 6 | 167 | 0 | 1,807 |
| 2024 | 6 | 43 | 2 | 1,913 |
| 2025 | 3 | 90 | 1 | 2,073 |
| 2026 | 4 | 205 | 0 | — |
What is it indicated for?
Symmetry™ and Symmetry Stiff Shaft Balloon Dilatation Catheters are indicated for Percutaneous Transluminal Angioplasty of narrowed or obstructed iliac, femoral or renal vessels in the peripheral vasculature.
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/K143193 · printed Nov 4, 2026
Cite this page
510(k) Report. “K143193: Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K143193
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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