510(k) · Cleared
ClearedPirouette 018
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arravasc Limited · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Aug 20, 2015 as substantially equivalent to K112335 (ClearStream Technologies, Ltd., 2011) and 2 other predicates after a 112-day review. Its family tree reaches back 9 generations to 2000. 4 later devices descend from it.
- Decided
- Aug 20, 2015
- Review
- 112 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K001134 (2000). 30 ancestors in all, the oldest K971010 (1997). 4 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 5 generations between
- 3 generations backK112797 Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corp. · 2012
- 2 generations backK121442 Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corporation · 2012 · Recalled
- 1 generation backK133843 Saber Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation · 2014 · Recalled
- This deviceK151153 Pirouette 018Arravasc Limited · 2015
- Descendant · cites it directly · 2 of its ownK162316 Pirouette 014Arravasc, Ltd. · 2016
- Descendant · cites it directly · 2 of its ownK161427 Pirouette 035Arravasc Limited · 2016
- Descendant · cites it directly · 1 of its ownK173621 Advocate PTA CatheterMerit Medical Systems, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK192907 Advocate PTA CatheterMerit Medical Systems, Inc. · 2019
Show all 9 generations
- Root · 9 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 8 generations backK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002 · Recalled
- 7 generations backK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
- 6 generations backK053118 Sterling Monorail Pta Balloon Dilatation Catheter, Model…Boston Scientific Corp · 2005
- 5 generations backK063563 Cordis Amila Percutaneous Transluminal Angioplasty (Pta) Balloon…Cordis Europa, N.V. · 2007
- 4 generations backK071189 Cordis Aviator Plus Pta Balloon Dilatation CatheterCordis Europa, N.V. · 2007
- 3 generations backK112797 Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corp. · 2012
- 2 generations backK121442 Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corporation · 2012 · Recalled
- 1 generation backK133843 Saber Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation · 2014 · Recalled
- This deviceK151153 Pirouette 018Arravasc Limited · 2015
Most influential descendants
Showing 4 of 4 · See all- K162316Pirouette 014Arravasc, Ltd. · 2016 · cites it directly2descendants
- K161427Pirouette 035Arravasc Limited · 2016 · cites it directly2descendants
- K173621Advocate PTA CatheterMerit Medical Systems, Inc. · 2017 · cites it directly1descendant
- K192907Advocate PTA CatheterMerit Medical Systems, Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K001134 | Gazelle Balloon Dilatation Catheter | Boston Scientific Corp | 2000 | — |
| −8 | K021735 | Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Scimed, Inc. | 2002 | 23 |
| −7 | K050389 | Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Corp | 2005 | — |
| −6 | K053118 | Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-Xxxxxx | Boston Scientific Corp | 2005 | — |
| −5 | K063563 | Cordis Amila Percutaneous Transluminal Angioplasty (Pta) Balloon Dilatation… | Cordis Europa, N.V. | 2007 | — |
| −4 | K071189 | Cordis Aviator Plus Pta Balloon Dilatation Catheter | Cordis Europa, N.V. | 2007 | — |
| −3 | K112797 | Powerflex Pro Percutaneous Transluminal Angioplasty Catheter | Cordis Corp. | 2012 | — |
| −2 | K121442 | Powerflex Pro Percutaneous Transluminal Angioplasty Catheter | Cordis Corporation | 2012 | 2 |
| −1 | K133843 | Saber Percutaneous Transluminal Angioplasty Dilatation Catheter | Cordis Corporation | 2014 | 1 |
| 0 (this device) | K151153 | Pirouette 018 | Arravasc Limited | 2015 | — |
| +1 | K162316 | Pirouette 014 | Arravasc, Ltd. | 2016 | — |
| +1 | K161427 | Pirouette 035 | Arravasc Limited | 2016 | — |
| +1 | K173621 | Advocate PTA Catheter | Merit Medical Systems, Inc. | 2017 | — |
| +2 | K192907 | Advocate PTA Catheter | Merit Medical Systems, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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? (3)
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 |
|---|---|---|---|
| * | K112335 | Bantam Catheter (280MM Balloon Lengths)Summary page 4…Primary predicate: Bantam and Bantam α OTW PTA Catheter Clearstream Technologies Ltd. 510(K) number: K112335/K093139 TM Secondary predicate: SABER PTA Dilation Catheter… | 2011 |
| * | K093139 | Bantam,48XXXXXX, 50XXXXXXSummary page 4…ry predicate: Bantam and Bantam α OTW PTA Catheter Clearstream Technologies Ltd. 510(K) number: K112335/K093139 TM Secondary predicate: SABER PTA Dilation Catheter C… | 2009 |
| * | K133843 | Saber Percutaneous Transluminal Angioplasty Dilatation CatheterSummary page 4…TM Secondary predicate: SABER PTA Dilation Catheter Cordis Corporation 510(K) number: K133843 4. Device Description Device Description: The Pirouette 018 Percutaneous Transluminal Angioplasty (PTA)… | 2014 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 9 of the 30 ancestors have a recall of any class.
- Of its descendants, K162316 (Arravasc, Ltd., 2016) has gone furthest, with 2 descendants of its own.
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?
Pirouette 018 is intended for balloon dilation of the iliac, femoral, popliteal, infra-popliteal and renal arteries.
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/K151153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151153: Pirouette 018.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151153
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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