510(k) Report

510(k) · Cleared

Cleared

Amphirion Plus Pta Catheter

K121265510(k) SpecialCleared May 22, 201226-day reviewClass II21 CFR 870.1250

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronic, Inc. · LIT Catheter, Angioplasty, Peripheral, Transluminal

Cleared on May 22, 2012 as substantially equivalent to K052791 (Invatec Innovative Technologies, S.R.L., 2005) and 2 other predicates after a 26-day review. Its family tree reaches back 3 generations to 2004.

Decided
May 22, 2012
Review
26 days
Class
Class II
Product code
LIT
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K042538 (2004). 6 ancestors in all, the oldest K032737 (2003). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 1 other ancestor2004: 1 other ancestor2003: 1 other ancestorK042538 · Sailor Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model Saexxxxxxxxx · Invatec Innovative Technologies · 2004K062809 · Admiral Xtreme Pta Catheter · Invatec Innovative Technologies · 2006K092361 · Reef HP 0.035 Otw Pta Balloon Dilatation Catheter · Invatec S.P.A. · 200920002002200420062008201020122014
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor K092361 · Reef HP 0.035 Otw Pta Balloon Dilatation Catheter · Invatec S.P.A. · 2009K062809 · Admiral Xtreme Pta Catheter · Invatec Innovative Technologies · 2006K042538 · Sailor Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model Saexxxxxxxxx · Invatec Innovative Technologies · 20040
  1. Root · 3 generations backK042538 Sailor Plus Percutaneous Transluminal Angioplasty (Pta) Catheter…Invatec Innovative Technologies · 2004
  2. 2 generations backK062809 Admiral Xtreme Pta CatheterInvatec Innovative Technologies · 2006
  3. 1 generation backK092361 Reef HP 0.035 Otw Pta Balloon Dilatation CatheterInvatec S.P.A. · 2009
  4. This deviceK121265 Amphirion Plus Pta CatheterMedtronic, Inc. · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K042538Sailor Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model…Invatec Innovative Technologies2004—
−2K062809Admiral Xtreme Pta CatheterInvatec Innovative Technologies2006—
−1K092361Reef HP 0.035 Otw Pta Balloon Dilatation CatheterInvatec S.P.A.2009—
0 (this device)K121265Amphirion Plus Pta CatheterMedtronic, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200510
FIG. 1 — Lineage of K121265, 2004–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K241040 Amethyst HP PTA OTW 0.035 Catheterscore 13.9 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K052791Modification to: Amphirion Deep 0.014 Otw Pta Balloon Catheter
Summary page 2
…4 Predicate Devices: Amphirion M DEEP 0.014" OTW PTA Balloon Catheter (K052791 SE-I 1/04/2005) REEF HP 0.035" OTW PTA Balloon Dilatation Catheter (K092361 SE-i 0/29/2009) Submarine TM Plus PTA Catheter (K0425…
Invatec Innovative Technologies, S.R.L.20051
*K092361Reef HP 0.035 Otw Pta Balloon Dilatation Catheter
Summary page 2
…4 Predicate Devices: Amphirion M DEEP 0.014" OTW PTA Balloon Catheter (K052791 SE-I 1/04/2005) REEF HP 0.035" OTW PTA Balloon Dilatation Catheter (K092361 SE-i 0/29/2009) Submarine TM Plus PTA Catheter (K042537 SE-i 1/08/2004) Device Description: The Amphirion Plus PTA Catheter (als…
Invatec S.P.A.2009—
*K042537Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model Suvxxxxxxxxx
Summary page 2
…DEEP 0.014" OTW PTA Balloon Catheter (K052791 SE-I 1/04/2005) REEF HP 0.035" OTW PTA Balloon Dilatation Catheter (K092361 SE-i 0/29/2009) Submarine TM Plus PTA Catheter (K042537 SE-i 1/08/2004) Device Description: The Amphirion Plus PTA Catheter (also referred to as Amphirion Plus) is an over-the-wire Per…
Invatec Innovative Technologies2004—

Also cleared against K052791: 6 other devices →

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 8 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
  • 2 of the 6 ancestors have a recall of any class.
  • 6 other devices also cite its predicate K052791.

How does its category compare?

All LIT devices

LIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · LIT

3in 2025

2007: 62008: 82009: 72010: 132011: 102012: 192013: 142014: 122015: 192016: 112017: 92018: 62019: 42020: 92021: 42022: 82023: 62024: 62025: 32026 (partial year): 4
2007high 19 (2012) · low 3 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LIT

90in 2025

2007: 64 days median2008: 53 days median2009: 29 days median2010: 78 days median2011: 82 days median2012: 29 days median2013: 79 days median2014: 90 days median2015: 112 days median2016: 116 days median2017: 57 days median2018: 118 days median2019: 40 days median2020: 125 days median2021: 61 days median2022: 122 days median2023: 167 days median2024: 43 days median2025: 90 days median2026 (partial year): 205 days median
2007high 205 (2026) · low 29 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LIT

1in 2025

2009: 22010: 12013: 2, 2 Class I2014: 32016: 12018: 22019: 32021: 12024: 22025: 1
2007high 3 (2014) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · LIT

2,073in 2025

2007: 5772008: 5132009: 6232010: 8092011: 8572012: 1,2772013: 1,2422014: 1,1782015: 1,2792016: 1,5292017: 2,0812018: 2,1882019: 2,4052020: 2,4432021: 2,4922022: 2,1552023: 1,8072024: 1,9132025: 2,073
2007high 2,492 (2021) · low 513 (2008)2025

MAUDE reports naming product code LIT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20076640577
20088530513
20097292623
201013781809
201110820857
2012192901,277
201314792 (2)1,242
2014129031,178
20151911201,279
20161111611,529
201795702,081
2018611822,188
201944032,405
2020912502,443
202146112,492
2022812202,155
2023616701,807
202464321,913
202539012,073
202642050—

What is it indicated for?

The Amphirion Tm Plus PTA Catheter is intended to dilate stemosis in the iliac, femnoral, ilio-fernoral, popliteal, infra-popliteal. and renal arteries and for the treatment of obstructive lesions of native or synthetic arteuiovenoujs dialysis fistulae.

Indications for use as stated in the FDA summary.

Also cleared against K052791

6 other devices cite the same predicate.

  • K142954PTA 14 Balloon Dilatation Catheter OTWTexasmedical Technologies, Inc. · 2015
  • K123358Pacific PlusMedtronic Vascular · 2013
  • K102645Willow/Elm Pta Balloon Dilatation CatheterCreagh Medical, Ltd. · 2010
  • K102705Armada 14 Pta CatheterAbbott Vascular, Inc. · 2010
  • K083919Amphirion Deep 0.014 Otw Pta Balloon CatheterInvatec Innovative Technologies, S.R.L. · 20091 recall
  • K083139Vipersphere Pta Balloon CatheterCardiovascular Systems, Inc. · 2008

More from Medtronic, Inc.

6,442 FDA decisions under this applicant name. See the company

  • P220026/S019Symplicity G3 Renal Denervation RF GeneratorMedtronic, Inc. · 2026
  • P240036/S007OmniaSecure™ MRI SureScan™ Lead Model 3930MMedtronic, Inc. · 2026
  • P010015/S591Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1TR02); Serena…Medtronic, Inc. · 2026
  • P980035/S848Astra S DR MRI IPG (X3DR01); Astra S SR MRI IPG (X3SR01); Astra XT DR MRI IPG (X1DR01); Astra XT SR MRI IPG…Medtronic, Inc. · 2026
  • P860004/S462SynchroMed™ Infusion System, Ascenda ™ Intrathecal CathetersMedtronic, Inc. · 2026

Recent decisions in LIT

The LIT category page

  • K260416ZYLOX Hippo PTA Balloon Dilatation CatheterZylox Medtech Co., Ltd. · 2026
  • K254212NC PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd. · 2026
  • K260304WAVE PTA Balloon CatheterWAVE Medical AG · 2026
  • K252512Armada™ 14 NC PTA CatheterAbbott Medical · 2026
  • K251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd. · 2025

https://510kreport.com/device/K121265 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121265: Amphirion 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/K121265

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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