510(k) · Cleared
ClearedArmada 14 Pta Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Vascular, Inc. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Dec 7, 2010 as substantially equivalent to K072798 (Abbott Vascular-Vascular Solutions, 2008) and 3 other predicates after a 78-day review. Its family tree reaches back 7 generations to 2000. 4 later devices descend from it.
- Decided
- Dec 7, 2010
- Review
- 78 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K001134 (2000). 25 ancestors in all, the oldest K970299 (1997). 4 later devices descend from it, 4 citing it directly.
- 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 backK053118 Sterling Monorail Pta Balloon Dilatation Catheter, Model…Boston Scientific Corp · 2005
- 3 generations backK063563 Cordis Amila Percutaneous Transluminal Angioplasty (Pta) Balloon…Cordis Europa, N.V. · 2007
- 2 generations backK071189 Cordis Aviator Plus Pta Balloon Dilatation CatheterCordis Europa, N.V. · 2007
- 1 generation backK072798 Viatrac 14 Plus Peripheral Dilation CatheterAbbott Vascular-Vascular Solutions · 2008 · Recalled
- This deviceK102705 Armada 14 Pta CatheterAbbott Vascular, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK260304 WAVE PTA Balloon CatheterWAVE Medical AG · 2026
- Descendant · cites it directly · 0 of its ownK252512 Armada™ 14 NC PTA CatheterAbbott Medical · 2026
- Descendant · cites it directly · 0 of its ownK151317 Armada 18 PTA CatheterAbbott Vascular · 2015
- Descendant · cites it directly · 0 of its ownK121352 Armada 14XXT Pta CatheterAbbott Vascular · 2012
Most influential descendants
Showing 4 of 4 · See all- K260304WAVE PTA Balloon CatheterWAVE Medical AG · 2026 · cites it directly0descendants
- K252512Armada™ 14 NC PTA CatheterAbbott Medical · 2026 · cites it directly0descendants
- K151317Armada 18 PTA CatheterAbbott Vascular · 2015 · cites it directly0descendants
- K121352Armada 14XXT Pta CatheterAbbott Vascular · 2012 · cites it directly0descendants
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 | K053118 | Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-Xxxxxx | Boston Scientific Corp | 2005 | — |
| −3 | K063563 | Cordis Amila Percutaneous Transluminal Angioplasty (Pta) Balloon Dilatation… | Cordis Europa, N.V. | 2007 | — |
| −2 | K071189 | Cordis Aviator Plus Pta Balloon Dilatation Catheter | Cordis Europa, N.V. | 2007 | — |
| −1 | K072798 | Viatrac 14 Plus Peripheral Dilation Catheter | Abbott Vascular-Vascular Solutions | 2008 | 1 |
| 0 (this device) | K102705 | Armada 14 Pta Catheter | Abbott Vascular, Inc. | 2010 | — |
| +1 | K260304 | WAVE PTA Balloon Catheter | WAVE Medical AG | 2026 | — |
| +1 | K252512 | Armada™ 14 NC PTA Catheter | Abbott Medical | 2026 | — |
| +1 | K151317 | Armada 18 PTA Catheter | Abbott Vascular | 2015 | — |
| +1 | K121352 | Armada 14XXT Pta Catheter | Abbott Vascular | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K072798 | Viatrac 14 Plus Peripheral Dilation CatheterSummary page 1…, angioplasty, peripheral, transluminal Predicate Device Names VIATRAC 14 PLUS Peripheral Dilatation Catheter (K072798, cleared 01/21/08) Amphirion Deep 0.0 14 OTW PTA Balloon… | 2008 |
| * | K050073 | Modification to Amphirion Deep 0.014 Otw Pta Balloon CatheterSummary page 1…Catheter (K072798, cleared 01/21/08) Amphirion Deep 0.0 14 OTW PTA Balloon Catheter (K050073 cleared 2/11/05, K052791 cleared 11/04/05, and K083919, cleared 03/13/09) Device Descri… | 2005 |
| * | K052791 | Modification to: Amphirion Deep 0.014 Otw Pta Balloon CatheterSummary page 1…ared 01/21/08) Amphirion Deep 0.0 14 OTW PTA Balloon Catheter (K050073 cleared 2/11/05, K052791 cleared 11/04/05, and K083919, cleared 03/13/09) Device Description The Armada 14 PTA… | 2005 |
| * | K083919 | Amphirion Deep 0.014 Otw Pta Balloon CatheterSummary page 1…0.0 14 OTW PTA Balloon Catheter (K050073 cleared 2/11/05, K052791 cleared 11/04/05, and K083919, cleared 03/13/09) Device Description The Armada 14 PTA Catheter is a standard over-the-wire (OTW) balloon catheter to be used… | 2009 |
What descends from it? (4)
4 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 10 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 6 of the 25 ancestors have a recall of any class.
- Of its descendants, K260304 (WAVE Medical AG, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K072798.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 indicated to dilate stenoses in femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The 2.0 to 4.0 mm balloon diameters are also indicated for post-dilatation of balloon-expandable stents up to 40 mm and self-expanding stents up to 80 mm in the vessels listed above.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102705 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102705: Armada 14 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/K102705
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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