510(k) · Cleared
Recalled · 2009Viatrac 14 Plus Peripheral Dilation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Vascular-Vascular Solutions · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Jan 31, 2008 as substantially equivalent to K012050 (Guidant Corp., 2001) and 2 other predicates after a 122-day review. Its family tree reaches back 6 generations to 2000. 6 later devices descend from it. It has been recalled once.
- Decided
- Jan 31, 2008
- Review
- 122 days
- Class
- Class II
- Product code
- LIT
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 6 generations to K001134 (2000). 18 ancestors in all, the oldest K970299 (1997). 6 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 5 generations backK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002 · Recalled
- 4 generations backK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
- 3 generations backK053118 Sterling Monorail Pta Balloon Dilatation Catheter, Model…Boston Scientific Corp · 2005
- 2 generations backK063563 Cordis Amila Percutaneous Transluminal Angioplasty (Pta) Balloon…Cordis Europa, N.V. · 2007
- 1 generation backK071189 Cordis Aviator Plus Pta Balloon Dilatation CatheterCordis Europa, N.V. · 2007
- This deviceK072798 Viatrac 14 Plus Peripheral Dilation CatheterAbbott Vascular-Vascular Solutions · 2008
- Descendant · cites it directly · 4 of its ownK102705 Armada 14 Pta CatheterAbbott Vascular, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK260304 WAVE PTA Balloon CatheterWAVE Medical AG · 2026
- Descendant · 2 generations on · 0 of its ownK252512 Armada™ 14 NC PTA CatheterAbbott Medical · 2026
- Descendant · cites it directly · 0 of its ownK221057 Viatrac 14 Plus Peripheral Dilatation CatheterAbbott Vascular · 2022
- Descendant · 2 generations on · 0 of its ownK151317 Armada 18 PTA CatheterAbbott Vascular · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K102705Armada 14 Pta CatheterAbbott Vascular, Inc. · 2010 · cites it directly4descendants
- K260304WAVE PTA Balloon CatheterWAVE Medical AG · 2026 · 2 generations on0descendants
- K252512Armada™ 14 NC PTA CatheterAbbott Medical · 2026 · 2 generations on0descendants
- K221057Viatrac 14 Plus Peripheral Dilatation CatheterAbbott Vascular · 2022 · cites it directly0descendants
- K151317Armada 18 PTA CatheterAbbott Vascular · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001134 | Gazelle Balloon Dilatation Catheter | Boston Scientific Corp | 2000 | — |
| −5 | K021735 | Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Scimed, Inc. | 2002 | 23 |
| −4 | K050389 | Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Corp | 2005 | — |
| −3 | K053118 | Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-Xxxxxx | Boston Scientific Corp | 2005 | — |
| −2 | 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 | — |
| 0 (this device) | K072798 | Viatrac 14 Plus Peripheral Dilation Catheter | Abbott Vascular-Vascular Solutions | 2008 | — |
| +1 | K102705 | Armada 14 Pta Catheter | Abbott Vascular, Inc. | 2010 | — |
| +2 | K260304 | WAVE PTA Balloon Catheter | WAVE Medical AG | 2026 | — |
| +2 | K252512 | Armada™ 14 NC PTA Catheter | Abbott Medical | 2026 | — |
| +1 | K221057 | Viatrac 14 Plus Peripheral Dilatation Catheter | Abbott Vascular | 2022 | — |
| +2 | K151317 | Armada 18 PTA Catheter | Abbott Vascular | 2015 | — |
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 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K012050 | Viatrac 14 Plus Peripheral Dilatation CatheterSummary page 1…ivalence: The Viatrac 14 PLUS Peripheral Dilatation Catheter with modified indications is substantially equivalent to the Viatrac 14 PLUS Peripheral Dilatation Catheter (K012050, cleared 09/06/2001) in addition to the currently marketed predicate devices, the Sterling Monorail PTA Balloon Dilatation Cathet… | 2001 |
| * | K053118 | Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-XxxxxxSummary page 1…ipheral Dilatation Catheter (K012050, cleared 09/06/2001) in addition to the currently marketed predicate devices, the Sterling Monorail PTA Balloon Dilatation Catheter, K053118 and the Cordis Aviator PLUS Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter, K071189. Changes made to the Viatrac 14… | 2005 |
| * | K071189 | Cordis Aviator Plus Pta Balloon Dilatation CatheterSummary page 1…edicate devices, the Sterling Monorail PTA Balloon Dilatation Catheter, K053118 and the Cordis Aviator PLUS Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter, K071189. Changes made to the Viatrac 14 PLUS Peripheral Dilatation Catheter will more closely align the indications with Clinical use. Th… | 2007 |
What descends from it? (6)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 6, 2009 | Not classified | Z-1178-2010 | Labeling mix-ups | Abbott Vascular is initiating a recall on the Viatrac 14 Plus 5.0x15 mm Peripheral Dilation Catheter due to a mistake in labeling/packaging. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 18 ancestors has a recall of any class.
- Of its descendants, K102705 (Abbott Vascular, Inc., 2010) has gone furthest, with 4 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. 2008, 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 Viatrac® 14 PLUS Peripheral Dilatation Catheter is indicated to dilate stenosis in the peripheral vasculature (iliac, femoral, ilio-femoral, popliteal, infra-popliteal, renal arteries, and carotid arties) 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 stents in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072798 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072798: Viatrac 14 Plus Peripheral Dilation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072798
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