510(k) · Cleared
ClearedRX Viatrac 14 Peripheral Dilatation Catheter, Model #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guidant Corp. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Dec 30, 1998 as substantially equivalent to K970299 (Cordis Corp., 1997) and 1 other predicate after a 120-day review. Its family tree reaches back 1 generation to 1997. 11 later devices descend from it.
- Decided
- Dec 30, 1998
- Review
- 120 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K970299 (1997). 2 ancestors in all. 11 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK970299 Jupiter Pta Catheters (Various)Cordis Corp. · 1997
- This deviceK983055 RX Viatrac 14 Peripheral Dilatation Catheter, Model #'S 1003006-20…Guidant Corp. · 1998
- Descendant · cites it directly · 7 of its ownK012050 Viatrac 14 Plus Peripheral Dilatation CatheterGuidant Corp. · 2001
- Descendant · 2 generations on · 6 of its ownK072798 Viatrac 14 Plus Peripheral Dilation CatheterAbbott Vascular-Vascular Solutions · 2008 · Recalled
- Descendant · 3 generations on · 4 of its ownK102705 Armada 14 Pta CatheterAbbott Vascular, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK033875 Atb All-Terrain Balloon Pta Dilatation CatheterCook, Inc. · 2004
- Descendant · 4 generations on · 0 of its ownK260304 WAVE PTA Balloon CatheterWAVE Medical AG · 2026
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K012050Viatrac 14 Plus Peripheral Dilatation CatheterGuidant Corp. · 2001 · cites it directly7descendants
- K072798Viatrac 14 Plus Peripheral Dilation CatheterAbbott Vascular-Vascular Solutions · 2008 · 2 generations on6descendants
- K102705Armada 14 Pta CatheterAbbott Vascular, Inc. · 2010 · 3 generations on4descendants
- K033875Atb All-Terrain Balloon Pta Dilatation CatheterCook, Inc. · 2004 · cites it directly1descendant
- K260304WAVE PTA Balloon CatheterWAVE Medical AG · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970299 | Jupiter Pta Catheters (Various) | Cordis Corp. | 1997 | — |
| 0 (this device) | K983055 | RX Viatrac 14 Peripheral Dilatation Catheter, Model #'S 1003006-20… | Guidant Corp. | 1998 | — |
| +1 | K012050 | Viatrac 14 Plus Peripheral Dilatation Catheter | Guidant Corp. | 2001 | — |
| +2 | K072798 | Viatrac 14 Plus Peripheral Dilation Catheter | Abbott Vascular-Vascular Solutions | 2008 | 1 |
| +3 | K102705 | Armada 14 Pta Catheter | Abbott Vascular, Inc. | 2010 | — |
| +1 | K033875 | Atb All-Terrain Balloon Pta Dilatation Catheter | Cook, Inc. | 2004 | — |
| +4 | K260304 | WAVE PTA Balloon Catheter | WAVE Medical AG | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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? (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 |
|---|---|---|---|
| * | K970299 | Jupiter Pta Catheters (Various)Summary page 1…atation Catheter Device Common Name: Percutaneous Transluminal Angioplasty Catheter Device Classification Name: LIT 3. Predicate Devices: Cordis Jupiter™ PTA Catheter (K970299) Cordis OPTA 5™ PTA Catheter (K972825) 4. Device Description: The RX VIATRAC™ 14 Peripheral Dilatation Catheter is a rapid exch… | 1997 |
| * | K972825 | OPTA5 Pta Balloon Catheter, Powerflex Pta Balloon Catheter, Ultra-Thin Diamond Balloon…Summary page 1…ercutaneous Transluminal Angioplasty Catheter Device Classification Name: LIT 3. Predicate Devices: Cordis Jupiter™ PTA Catheter (K970299) Cordis OPTA 5™ PTA Catheter (K972825) 4. Device Description: The RX VIATRAC™ 14 Peripheral Dilatation Catheter is a rapid exchange catheter with an integrated shaft… | 1997 |
What descends from it? (11)
See all 113 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K012050 (Guidant Corp., 2001) has gone furthest, with 7 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.
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 RX VIATRAC™ 14 Peripheral Dilatation Catheter is indicated for dilatation of stenoses 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. In addition, the RX VIATRAC™ 14 Peripheral Dilatation Catheter is indicated for balloon dilatation of the PALMAZ™ P204 stent following implantation. It is not intended for use in the coronary vasculature.
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/K983055 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983055: RX Viatrac 14 Peripheral Dilatation Catheter, Model #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983055
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