510(k) · Cleared
ClearedRX Viatrac 18 Peripheral Dilatation Catheter, Otw Viatrac 18 Peripheral Dilatation Catheter
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 Jan 27, 2000 as substantially equivalent to K983055 (Guidant Corp., 1998) and 1 other predicate after a 91-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Jan 27, 2000
- Review
- 91 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K970299 (1997). 3 ancestors in all. No later device cites it as a predicate yet.
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) | K993639 | RX Viatrac 18 Peripheral Dilatation Catheter, Otw Viatrac 18 Peripheral… | Guidant Corp. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 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 |
|---|---|---|---|
| * | K983055 | RX Viatrac 14 Peripheral Dilatation Catheter, Model #'S 1003006-20, 1003007-20…Summary page 1…Device Common Name: Percutaneous Transluminal Angioplasty Catheter Device Classification Name: LIT Predicate Devices: = RX VIATRAC™ 14 Peripheral Dilatation Catheter (K983055) Cordis OPTA 5™ PTA Catheter (K972825) Device Description: The RX VIATRAC™ 18 and the OTW VIATRAC™ 18 Peripheral Dilatation Cat… | 1998 |
| * | K972825 | OPTA5 Pta Balloon Catheter, Powerflex Pta Balloon Catheter, Ultra-Thin Diamond Balloon…Summary page 1…sluminal Angioplasty Catheter Device Classification Name: LIT Predicate Devices: = RX VIATRAC™ 14 Peripheral Dilatation Catheter (K983055) Cordis OPTA 5™ PTA Catheter (K972825) Device Description: The RX VIATRAC™ 18 and the OTW VIATRAC™ 18 Peripheral Dilatation Catheters were developed in parallel as t… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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 3 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K983055.
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™ 18 Peripheral Dilatation Catheter is intended: To dilate stenoses in the peripheral arteries (iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries) For the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. For post deployment optimization of the 28 mm GUIDANT MEGALINK™ Biliary Stent (6.0 to 10.0 mm diameters). The OTW VIATRAC™ 18 Peripheral Dilatation Catheter is intended: To…
Read the full statement (108 words)
The RX VIATRAC™ 18 Peripheral Dilatation Catheter is intended:
To dilate stenoses in the peripheral arteries (iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries)
For the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
For post deployment optimization of the 28 mm GUIDANT MEGALINK™ Biliary Stent (6.0 to 10.0 mm diameters).
The OTW VIATRAC™ 18 Peripheral Dilatation Catheter is intended:
To dilate stenoses in the peripheral arteries (iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries)
For the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
For post deployment optimization of the 28 mm GUIDANT MEGALINK™ Biliary Stent (6.0 to 10.0 mm diameters).
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/K993639 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993639: RX Viatrac 18 Peripheral Dilatation Catheter, Otw Viatrac 18 Peripheral Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993639
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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