510(k) · Cleared
ClearedCordis Amiia .014 Pta Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Corp. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Apr 1, 2005 as substantially equivalent to K013581 (Cordis, A Johnson & Johnson Co., 2001) and 1 other predicate after an 18-day review. Its family tree reaches back 2 generations to 1997. 25 later devices descend from it.
- Decided
- Apr 1, 2005
- Review
- 18 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K971448 (1997). 6 ancestors in all. 25 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK971448 Cordis Opta LP Pta Balloon CatheterCordis Corp. · 1997
- 1 generation backK013581 Cordis Aviator Peripheral Dilatation CatheterCordis, A Johnson & Johnson Co. · 2001
- This deviceK050645 Cordis Amiia .014 Pta Balloon CatheterCordis Corp. · 2005
- Descendant · cites it directly · 24 of its ownK063563 Cordis Amila Percutaneous Transluminal Angioplasty (Pta) Balloon…Cordis Europa, N.V. · 2007
- Descendant · cites it directly · 23 of its ownK071189 Cordis Aviator Plus Pta Balloon Dilatation CatheterCordis Europa, N.V. · 2007
- Descendant · 2 generations on · 10 of its ownK112797 Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corp. · 2012
- Descendant · 3 generations on · 9 of its ownK121442 Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corporation · 2012 · Recalled
- Descendant · 4 generations on · 6 of its ownK133843 Saber Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation · 2014 · Recalled
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K063563Cordis Amila Percutaneous Transluminal Angioplasty (Pta) Balloon Dilatation CatheterCordis Europa, N.V. · 2007 · cites it directly24descendants
- K071189Cordis Aviator Plus Pta Balloon Dilatation CatheterCordis Europa, N.V. · 2007 · cites it directly23descendants
- K112797Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corp. · 2012 · 2 generations on10descendants
- K121442Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corporation · 2012 · 3 generations on9descendants
- K133843Saber Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation · 2014 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971448 | Cordis Opta LP Pta Balloon Catheter | Cordis Corp. | 1997 | — |
| −1 | K013581 | Cordis Aviator Peripheral Dilatation Catheter | Cordis, A Johnson & Johnson Co. | 2001 | — |
| 0 (this device) | K050645 | Cordis Amiia .014 Pta Balloon Catheter | Cordis Corp. | 2005 | — |
| +1 | K063563 | Cordis Amila Percutaneous Transluminal Angioplasty (Pta) Balloon Dilatation… | Cordis Europa, N.V. | 2007 | — |
| +1 | K071189 | Cordis Aviator Plus Pta Balloon Dilatation Catheter | Cordis Europa, N.V. | 2007 | — |
| +2 | K112797 | Powerflex Pro Percutaneous Transluminal Angioplasty Catheter | Cordis Corp. | 2012 | — |
| +3 | K121442 | Powerflex Pro Percutaneous Transluminal Angioplasty Catheter | Cordis Corporation | 2012 | 2 |
| +4 | K133843 | Saber Percutaneous Transluminal Angioplasty Dilatation Catheter | Cordis Corporation | 2014 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K013581 | Cordis Aviator Peripheral Dilatation CatheterSummary page 1…diovascular Product Code: LIT Predicate The predicate devices in this submission are the Cordis AVIATOR (510(k) Device(s) #K013581) and the Cordis M3 PTA Balloon Catheters (510(k) #K003920, which have been determined substantial equivalent on N… | 2001 |
| * | K003920 | Cordis M3 Pta Dilatation CatheterSummary page 1…LIT Predicate The predicate devices in this submission are the Cordis AVIATOR (510(k) Device(s) #K013581) and the Cordis M3 PTA Balloon Catheters (510(k) #K003920, which have been determined substantial equivalent on November 28, 2001 and June 15, 2001 respect… | 2001 |
What descends from it? (25)
See all 252 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 8 years and passes through 2 companies; a new generation was cleared every 4.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K063563 (Cordis Europa, N.V., 2007) has gone furthest, with 24 descendants of its own.
- 3 other devices also cite its predicate K013581.
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?
The Cordis AMIIA PTA catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050645 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050645: Cordis Amiia .014 Pta Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050645
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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