510(k) · Cleared
ClearedPacific Plus PTA Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular,Inc (Formerly D.B.A Ev3 Inc.,Covidien, LLC) · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Nov 18, 2020 as substantially equivalent to K123358 (Medtronic Vascular, 2013) after a 56-day review. Its family tree reaches back 5 generations to 2004.
- Decided
- Nov 18, 2020
- Review
- 56 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K042537 (2004). 13 ancestors in all, the oldest K032737 (2003). No later device cites it as a predicate yet.
- Root · 5 generations backK042537 Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter…Invatec Innovative Technologies · 2004
- 4 generations backK072947 Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta)…ClearStream Technologies, Ltd. · 2008
- 3 generations backK083919 Amphirion Deep 0.014 Otw Pta Balloon CatheterInvatec Innovative Technologies, S.R.L. · 2009 · Recalled
- 2 generations backK103464 Pacific Xtreme Ptca Balloon Dilatation CatheterMedtronic, Inc. · 2010 · Recalled
- 1 generation backK123358 Pacific PlusMedtronic Vascular · 2013
- This deviceK202800 Pacific Plus PTA CatheterMedtronic Vascular,Inc (Formerly D.B.A Ev3 Inc.,Covidien, LLC) · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K042537 | Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model… | Invatec Innovative Technologies | 2004 | — |
| −4 | K072947 | Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) Catheters | ClearStream Technologies, Ltd. | 2008 | — |
| −3 | K083919 | Amphirion Deep 0.014 Otw Pta Balloon Catheter | Invatec Innovative Technologies, S.R.L. | 2009 | 1 |
| −2 | K103464 | Pacific Xtreme Ptca Balloon Dilatation Catheter | Medtronic, Inc. | 2010 | 1 |
| −1 | K123358 | Pacific Plus | Medtronic Vascular | 2013 | — |
| 0 (this device) | K202800 | Pacific Plus PTA Catheter | Medtronic Vascular,Inc (Formerly D.B.A Ev3 Inc.,Covidien, LLC) | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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? (1)
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 |
|---|---|---|---|
| * | K123358 | Pacific PlusSummary page 4…ovascular Regulation Number 21 CFR§870.1250 3. Predicate Device Device Trade Name Pacific Plus PTA Catheter (Primary Predicate) 510(k) Number K123358 510(k) Clearance Date January 29, 2013 4. Reference Devices Device Trade Name PowerCross .018” OTW PTA Dilatation Cat… | 2013 |
| † | K093286 | Powercross .018 Otw Pta Dilation Catheter | 2009 |
| † | K103464 | Pacific Xtreme Ptca Balloon Dilatation Catheter | 2010 |
| † | K192318 | Ultraverse 014 and 018 PTA Balloon Dilatation Catheters | 2019 |
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 16 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 6 of the 13 ancestors have a recall of any class.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Pacific Plus PTA Catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent postdilatation in the peripheral arteries.
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/K202800 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202800: Pacific Plus PTA Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202800
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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