510(k) · Cleared
ClearedSymmetry Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Apr 12, 2006 as substantially equivalent to K953602 (Boston Scientific Corp, 1995) and 1 other predicate after a 5-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Apr 12, 2006
- Review
- 5 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K953602 (1995). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK953602 Symmetry Small Vessel Balloon Dilatation CatheterBoston Scientific Corp · 1995
- This deviceK060959 Symmetry Balloon Dilatation CatheterBoston Scientific Corporation · 2006
- Descendant · cites it directly · 0 of its ownK143193 Symmetry and Symmetry Stiff Shaft Balloon Dilatation CathetersBoston Scientific · 2015
Most influential descendants
Showing 1 of 1 · See all- K143193Symmetry and Symmetry Stiff Shaft Balloon Dilatation CathetersBoston Scientific · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953602 | Symmetry Small Vessel Balloon Dilatation Catheter | Boston Scientific Corp | 1995 | — |
| 0 (this device) | K060959 | Symmetry Balloon Dilatation Catheter | Boston Scientific Corporation | 2006 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (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 |
|---|---|---|---|
| * | K953602 | Symmetry Small Vessel Balloon Dilatation CatheterSummary page 1…e Balloon Dilatation Catheter Product Code LIT Classification of Class II,21 CFR Part 870.1250 Device Predicate Device Symmetry Balloon K953602 October 18, 1995 Dilatation Catheter Device The Symmetry Balloon Dilatation Catheter is… | 1995 |
| * | K000798 | Talon Balloon Dilation CatheterSummary page 2…shown to be equivalent in intended use and is considered to be substantially equivalent to the Symmetry Balloon Dilatation Catheter (K000798; cleared October 18, 1995). DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143193 | Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters | 2015 | 0 |
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?
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 recommended for Percutaneous Transluminal Angioplasty of small, narrowed or obstructed iliac, femoral, or renal vessels in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060959 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060959: Symmetry Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060959
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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