510(k) · Cleared
ClearedCordis Aviator Plus Pta Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Europa, N.V. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on May 16, 2007 as substantially equivalent to K063563 (Cordis Europa, N.V., 2007) and 1 other predicate after a 16-day review. Its family tree reaches back 5 generations to 2000. 23 later devices descend from it.
- Decided
- May 16, 2007
- Review
- 16 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K001134 (2000). 12 ancestors in all, the oldest K971448 (1997). 23 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 4 generations backK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002 · Recalled
- 3 generations backK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
- 2 generations backK053118 Sterling Monorail Pta Balloon Dilatation Catheter, Model…Boston Scientific Corp · 2005
- 1 generation backK063563 Cordis Amila Percutaneous Transluminal Angioplasty (Pta) Balloon…Cordis Europa, N.V. · 2007
- This deviceK071189 Cordis Aviator Plus Pta Balloon Dilatation CatheterCordis Europa, N.V. · 2007
- Descendant · cites it directly · 10 of its ownK112797 Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corp. · 2012
- Descendant · 2 generations on · 9 of its ownK121442 Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corporation · 2012 · Recalled
- Descendant · 3 generations on · 6 of its ownK133843 Saber Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation · 2014 · Recalled
- Descendant · cites it directly · 6 of its ownK072798 Viatrac 14 Plus Peripheral Dilation CatheterAbbott Vascular-Vascular Solutions · 2008 · Recalled
- Descendant · 4 generations on · 4 of its ownK151153 Pirouette 018Arravasc Limited · 2015
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K112797Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corp. · 2012 · cites it directly10descendants
- K121442Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corporation · 2012 · 2 generations on9descendants
- K133843Saber Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation · 2014 · 3 generations on6descendants
- K072798Viatrac 14 Plus Peripheral Dilation CatheterAbbott Vascular-Vascular Solutions · 2008 · cites it directly6descendants
- K151153Pirouette 018Arravasc Limited · 2015 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001134 | Gazelle Balloon Dilatation Catheter | Boston Scientific Corp | 2000 | — |
| −4 | K021735 | Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Scimed, Inc. | 2002 | 23 |
| −3 | K050389 | Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Corp | 2005 | — |
| −2 | K053118 | Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-Xxxxxx | Boston Scientific Corp | 2005 | — |
| −1 | K063563 | Cordis Amila Percutaneous Transluminal Angioplasty (Pta) Balloon Dilatation… | Cordis Europa, N.V. | 2007 | — |
| 0 (this device) | K071189 | Cordis Aviator Plus Pta Balloon Dilatation Catheter | Cordis Europa, N.V. | 2007 | — |
| +1 | K112797 | Powerflex Pro Percutaneous Transluminal Angioplasty Catheter | Cordis Corp. | 2012 | — |
| +2 | K121442 | Powerflex Pro Percutaneous Transluminal Angioplasty Catheter | Cordis Corporation | 2012 | 2 |
| +3 | K133843 | Saber Percutaneous Transluminal Angioplasty Dilatation Catheter | Cordis Corporation | 2014 | 1 |
| +1 | K072798 | Viatrac 14 Plus Peripheral Dilation Catheter | Abbott Vascular-Vascular Solutions | 2008 | 1 |
| +4 | K151153 | Pirouette 018 | Arravasc Limited | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K063563 | Cordis Amila Percutaneous Transluminal Angioplasty (Pta) Balloon Dilatation CatheterSummary page 1…roduct Code: LIT Predicate The predicate device in this submission is the Cordis AMIIA PTA Balloon Device(s) Dilatation Catheter (510(k) #K063563 & #K050645), which was determined substantial equivalent on March 7, 2007 and April 1, 2005 respectively. Devi… | 2007 |
| * | K050645 | Cordis Amiia .014 Pta Balloon CatheterSummary page 1…: LIT Predicate The predicate device in this submission is the Cordis AMIIA PTA Balloon Device(s) Dilatation Catheter (510(k) #K063563 & #K050645), which was determined substantial equivalent on March 7, 2007 and April 1, 2005 respectively. Device… | 2005 |
What descends from it? (23)
See all 234 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 7 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K112797 (Cordis Corp., 2012) has gone furthest, with 10 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. 2007, 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?
The Cordis AVIATOR PLUS PTA Balloon Dilatation catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal, and carotid arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon-expandable and self-expanding stems in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071189 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071189: Cordis Aviator Plus Pta Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071189
Report an extraction error
Are you the manufacturer?
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