510(k) · Cleared
ClearedViatrac 14 Plus Peripheral Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guidant Corp. · DQY Catheter, Percutaneous
Cleared on Sep 6, 2001 as substantially equivalent to K983055 (Guidant Corp., 1998) and 1 other predicate after a 66-day review. Its family tree reaches back 2 generations to 1997. 7 later devices descend from it.
- Decided
- Sep 6, 2001
- Review
- 66 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K970299 (1997). 4 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK970299 Jupiter Pta Catheters (Various)Cordis Corp. · 1997
- 1 generation backK983055 RX Viatrac 14 Peripheral Dilatation Catheter, Model #'S 1003006-20…Guidant Corp. · 1998
- This deviceK012050 Viatrac 14 Plus Peripheral Dilatation CatheterGuidant Corp. · 2001
- Descendant · cites it directly · 6 of its ownK072798 Viatrac 14 Plus Peripheral Dilation CatheterAbbott Vascular-Vascular Solutions · 2008 · Recalled
- Descendant · 2 generations on · 4 of its ownK102705 Armada 14 Pta CatheterAbbott Vascular, Inc. · 2010
- Descendant · 3 generations on · 0 of its ownK260304 WAVE PTA Balloon CatheterWAVE Medical AG · 2026
- Descendant · 3 generations on · 0 of its ownK252512 Armada™ 14 NC PTA CatheterAbbott Medical · 2026
- Descendant · 2 generations on · 0 of its ownK221057 Viatrac 14 Plus Peripheral Dilatation CatheterAbbott Vascular · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K072798Viatrac 14 Plus Peripheral Dilation CatheterAbbott Vascular-Vascular Solutions · 2008 · cites it directly6descendants
- K102705Armada 14 Pta CatheterAbbott Vascular, Inc. · 2010 · 2 generations on4descendants
- K260304WAVE PTA Balloon CatheterWAVE Medical AG · 2026 · 3 generations on0descendants
- K252512Armada™ 14 NC PTA CatheterAbbott Medical · 2026 · 3 generations on0descendants
- K221057Viatrac 14 Plus Peripheral Dilatation CatheterAbbott Vascular · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970299 | Jupiter Pta Catheters (Various) | Cordis Corp. | 1997 | — |
| −1 | K983055 | RX Viatrac 14 Peripheral Dilatation Catheter, Model #'S 1003006-20… | Guidant Corp. | 1998 | — |
| 0 (this device) | K012050 | Viatrac 14 Plus Peripheral Dilatation Catheter | Guidant Corp. | 2001 | — |
| +1 | K072798 | Viatrac 14 Plus Peripheral Dilation Catheter | Abbott Vascular-Vascular Solutions | 2008 | 1 |
| +2 | K102705 | Armada 14 Pta Catheter | Abbott Vascular, Inc. | 2010 | — |
| +3 | K260304 | WAVE PTA Balloon Catheter | WAVE Medical AG | 2026 | — |
| +3 | K252512 | Armada™ 14 NC PTA Catheter | Abbott Medical | 2026 | — |
| +2 | K221057 | Viatrac 14 Plus Peripheral Dilatation Catheter | Abbott Vascular | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 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 DQY? 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 DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 6 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 |
|---|---|---|---|
| * | K983055 | RX Viatrac 14 Peripheral Dilatation Catheter, Model #'S 1003006-20, 1003007-20…Summary page 1…LUS Peripheral Dilatation Catheter are substantially equivalent with regard to these features in the predicate device, the RX VIATRAC™ 14 Peripheral Dilatation Catheter (K983055 and K000101). Device Description: The VIATRAC™ 14 PLUS Peripheral Dilatation Catheter is a rapid exchange catheter with an inte… | 1998 |
| * | K000101 | RX Viatrac 14 Peripheral Dilatation CatheterSummary page 1…al Dilatation Catheter are substantially equivalent with regard to these features in the predicate device, the RX VIATRAC™ 14 Peripheral Dilatation Catheter (K983055 and K000101). Device Description: The VIATRAC™ 14 PLUS Peripheral Dilatation Catheter is a rapid exchange catheter with an integrated shaft… | 2000 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072798 | Viatrac 14 Plus Peripheral Dilation Catheter | 2008 | 6 |
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 4 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K072798 (Abbott Vascular-Vascular Solutions, 2008) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K983055.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
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 and renal arteries) and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012050 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012050: Viatrac 14 Plus Peripheral 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/K012050
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026