510(k) · Cleared
ClearedPacific Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Jan 29, 2013 as substantially equivalent to K103464 (Medtronic, Inc., 2010) and 3 other predicates after a 90-day review. Its family tree reaches back 4 generations to 2004. 1 later device descends from it.
- Decided
- Jan 29, 2013
- Review
- 90 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K042537 (2004). 12 ancestors in all, the oldest K032737 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK042537 Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter…Invatec Innovative Technologies · 2004
- 3 generations backK072947 Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta)…ClearStream Technologies, Ltd. · 2008
- 2 generations backK083919 Amphirion Deep 0.014 Otw Pta Balloon CatheterInvatec Innovative Technologies, S.R.L. · 2009 · Recalled
- 1 generation backK103464 Pacific Xtreme Ptca Balloon Dilatation CatheterMedtronic, Inc. · 2010 · Recalled
- This deviceK123358 Pacific PlusMedtronic Vascular · 2013
- Descendant · cites it directly · 0 of its ownK202800 Pacific Plus PTA CatheterMedtronic Vascular,Inc (Formerly D.B.A Ev3 Inc.,Covidien, LLC) · 2020
Most influential descendants
Showing 1 of 1 · See all- K202800Pacific Plus PTA CatheterMedtronic Vascular,Inc (Formerly D.B.A Ev3 Inc.,Covidien, LLC) · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K042537 | Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model… | Invatec Innovative Technologies | 2004 | — |
| −3 | K072947 | Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) Catheters | ClearStream Technologies, Ltd. | 2008 | — |
| −2 | K083919 | Amphirion Deep 0.014 Otw Pta Balloon Catheter | Invatec Innovative Technologies, S.R.L. | 2009 | 1 |
| −1 | K103464 | Pacific Xtreme Ptca Balloon Dilatation Catheter | Medtronic, Inc. | 2010 | 1 |
| 0 (this device) | K123358 | Pacific Plus | Medtronic Vascular | 2013 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (4)
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 |
|---|---|---|---|
| * | K103464 | Pacific Xtreme Ptca Balloon Dilatation CatheterSummary page 2…4 Predicate Devices * PacificTM Xtreme PTA Balloon Dilatation Catheter (K103464 SE-12/22/2010) .Amphirionm DEEP 0.0 14" OTW PTA Balloon Catheter (K052791 SE-I 1/04/2005 and K083919.SE-03/13/2009) *… | 2010 |
| * | K052791 | Modification to: Amphirion Deep 0.014 Otw Pta Balloon CatheterSummary page 2…4 Predicate Devices * PacificTM Xtreme PTA Balloon Dilatation Catheter (K103464 SE-12/22/2010) .Amphirionm DEEP 0.0 14" OTW PTA Balloon Catheter (K052791 SE-I 1/04/2005 and K083919.SE-03/13/2009) * REEF HPTm 0.035" OTW PTA Balloon Dilatation Catheter (K(092361 SE-l0/29/2009)… | 2005 |
| * | K083919 | Amphirion Deep 0.014 Otw Pta Balloon CatheterSummary page 2…s * PacificTM Xtreme PTA Balloon Dilatation Catheter (K103464 SE-12/22/2010) .Amphirionm DEEP 0.0 14" OTW PTA Balloon Catheter (K052791 SE-I 1/04/2005 and K083919.SE-03/13/2009) * REEF HPTm 0.035" OTW PTA Balloon Dilatation Catheter (K(092361 SE-l0/29/2009) Reference Device *Amphirio… | 2009 |
| * | K092361 | Reef HP 0.035 Otw Pta Balloon Dilatation CatheterSummary page 2….Amphirionm DEEP 0.0 14" OTW PTA Balloon Catheter (K052791 SE-I 1/04/2005 and K083919.SE-03/13/2009) * REEF HPTm 0.035" OTW PTA Balloon Dilatation Catheter (K(092361 SE-l0/29/2009) Reference Device *Amphirion t m Plus PTA Catheter (K121265 SE-05/22/2012) Device Description The Pacific… | 2009 |
| † | K121265 | Amphirion Plus Pta Catheter | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202800 | Pacific Plus PTA Catheter | 2020 | 0 |
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 9 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 6 of the 12 ancestors have a recall of any class.
- Of its descendants, K202800 (Medtronic Vascular,Inc (Formerly D.B.A Ev3 Inc.,Covidien, LLC), 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K103464.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 PacificTM 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123358 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123358: Pacific Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123358
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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