510(k) · Cleared
ClearedJupiter Pta Catheters (Various)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Corp. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Apr 24, 1997 after an 87-day review. The FDA summary names its predicate without a number. 12 later devices descend from it.
- Decided
- Apr 24, 1997
- Review
- 87 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 1 citing it directly.
- This deviceK970299 Jupiter Pta Catheters (Various)Cordis Corp. · 1997
- Descendant · cites it directly · 11 of its ownK983055 RX Viatrac 14 Peripheral Dilatation Catheter, Model #'S 1003006-20…Guidant Corp. · 1998
- Descendant · 2 generations on · 7 of its ownK012050 Viatrac 14 Plus Peripheral Dilatation CatheterGuidant Corp. · 2001
- Descendant · 3 generations on · 6 of its ownK072798 Viatrac 14 Plus Peripheral Dilation CatheterAbbott Vascular-Vascular Solutions · 2008 · Recalled
- Descendant · 4 generations on · 4 of its ownK102705 Armada 14 Pta CatheterAbbott Vascular, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK033875 Atb All-Terrain Balloon Pta Dilatation CatheterCook, Inc. · 2004
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K983055RX Viatrac 14 Peripheral Dilatation Catheter, Model #'S 1003006-20, 1003007-20…Guidant Corp. · 1998 · cites it directly11descendants
- K012050Viatrac 14 Plus Peripheral Dilatation CatheterGuidant Corp. · 2001 · 2 generations on7descendants
- K072798Viatrac 14 Plus Peripheral Dilation CatheterAbbott Vascular-Vascular Solutions · 2008 · 3 generations on6descendants
- K102705Armada 14 Pta CatheterAbbott Vascular, Inc. · 2010 · 4 generations on4descendants
- K033875Atb All-Terrain Balloon Pta Dilatation CatheterCook, Inc. · 2004 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970299 | Jupiter Pta Catheters (Various) | Cordis Corp. | 1997 | — |
| +1 | K983055 | RX Viatrac 14 Peripheral Dilatation Catheter, Model #'S 1003006-20… | Guidant Corp. | 1998 | — |
| +2 | K012050 | Viatrac 14 Plus Peripheral Dilatation Catheter | Guidant Corp. | 2001 | — |
| +3 | K072798 | Viatrac 14 Plus Peripheral Dilation Catheter | Abbott Vascular-Vascular Solutions | 2008 | 1 |
| +4 | K102705 | Armada 14 Pta Catheter | Abbott Vascular, Inc. | 2010 | — |
| +2 | K033875 | Atb All-Terrain Balloon Pta Dilatation Catheter | Cook, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | — | Jupiter PTA Catheters Named without a submission number | |
| * | — | Opta 5 PTA Catheters Named without a submission number | |
| * | — | Ultra Thin PTA Balloon Catheter Named without a submission number | |
| † | K955888 | Prepowdered Latex Examination Gloves | 1996 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983055 | RX Viatrac 14 Peripheral Dilatation Catheter, Model #'S 1003006-20, 1003007-20… | 1998 | 11 |
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?
- Of its descendants, K983055 (Guidant Corp., 1998) has gone furthest, with 11 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?
Jupiter PTA Catheters are designed for dilating stenotic atherosclerotic lesions in peripheral arteries (renal, popliteal, infra popliteal, femoral, and ilio femoral) and are also intended to treat 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/K970299 · printed Nov 5, 2026
Cite this page
510(k) Report. “K970299: Jupiter Pta Catheters (Various).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970299
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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