510(k) · Cleared
Recalled · Class II · 2012Armada 35/35LL Pta Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Vascular · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Oct 3, 2011 as substantially equivalent to K110319 (Ev3, Inc., 2011) and 2 other predicates after a 90-day review. Its family tree reaches back 7 generations to 2000. It has been recalled once.
- Decided
- Oct 3, 2011
- Review
- 90 days
- Class
- Class II
- Product code
- LIT
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 7 generations to K001134 (2000). 18 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 6 generations backK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002 · Recalled
- 5 generations backK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
- 4 generations backK053116 Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp · 2005
- 3 generations backK072283 Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2007 · Recalled
- 2 generations backK082579 Evercross .035 Otw Pta Dilatation CatheterEv3, Inc. · 2008 · Recalled
- 1 generation backK110319 Evercross 0.035 Otw Pta Dilatation CatheterEv3, Inc. · 2011
- This deviceK111899 Armada 35/35LL Pta CatheterAbbott Vascular · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001134 | Gazelle Balloon Dilatation Catheter | Boston Scientific Corp | 2000 | — |
| −6 | K021735 | Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Scimed, Inc. | 2002 | 23 |
| −5 | K050389 | Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Corp | 2005 | — |
| −4 | K053116 | Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx | Boston Scientific Corp | 2005 | — |
| −3 | K072283 | Dorado Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2007 | 15 |
| −2 | K082579 | Evercross .035 Otw Pta Dilatation Catheter | Ev3, Inc. | 2008 | 1 |
| −1 | K110319 | Evercross 0.035 Otw Pta Dilatation Catheter | Ev3, Inc. | 2011 | — |
| 0 (this device) | K111899 | Armada 35/35LL Pta Catheter | Abbott Vascular | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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? (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 |
|---|---|---|---|
| * | K110319 | Evercross 0.035 Otw Pta Dilatation Catheter | 2011 |
| * | K100921 | Admiral Xtreme Pta Balloon Dilatation CatheterSummary page 1…Catheter (KI 10319, cleared 04/14/1l) " Invatec Admiral XTREMETM PTA Balloon Dilatation Catheter (K100921, cleared 04/30/10) " Abbott Vascular's FoxCross PTA Catheter (K… | 2010 |
| * | K090509 | Foxcross .035 Pta Catheter 14 MM X 20MM X 80 CM, Model 10342-20, Foxcross .035 Pta…Summary page 1…Dilatation Catheter (K100921, cleared 04/30/10) " Abbott Vascular's FoxCross PTA Catheter (K090509, cleared 03/20/09) Device Description The Armada 35/Armada 35 LL Percutaneous Transluminal Angioplasty (PTA) Catheter is a stan… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 20, 2012 | Class II | Z-2450-2012 | Process design | Abbott Vascular is recalling the Armada 35 and Armada 35 LL PTA Catheters because they have discovered that some devices may exhibit difficulty inflating and/or deflating. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 4 of the 18 ancestors have a recall of any class.
- 3 other devices also cite its predicate K110319.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 device is intended for dilatation of lesions in the renal, iliac, femoral, popliteal, tibial, and peroneal, arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
This device is also indicated for stent post-dilatation in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111899 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111899: Armada 35/35LL Pta Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111899
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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