510(k) · Cleared

Recalled · Class II · 2015

Modification to Amphirion Deep 0.014 Otw Pta Balloon Catheter

K050073510(k) SpecialCleared Feb 11, 200530-day reviewClass II21 CFR 870.1250Recalls 1

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

Invatec Innovative Technologies, S.R.L. · DQY Catheter, Percutaneous

Cleared on Feb 11, 2005 after a 30-day review. The FDA summary names its predicate without a number. 28 later devices descend from it. It has been recalled once.

Decided: Feb 11, 2005
Review: 30 days
Class: Class II
Product code: DQY
Recalls: 1
Predicates: 0

28 later devices descend from it, 4 citing it directly.

This deviceK050073 Modification to Amphirion Deep 0.014 Otw Pta Balloon CatheterInvatec Innovative Technologies, S.R.L. · 2005
Descendant · cites it directly · 26 of its ownK083919 Amphirion Deep 0.014 Otw Pta Balloon CatheterInvatec Innovative Technologies, S.R.L. · 2009 · Recalled
Descendant · 2 generations on · 9 of its ownK103464 Pacific Xtreme Ptca Balloon Dilatation CatheterMedtronic, Inc. · 2010 · Recalled
Descendant · 3 generations on · 6 of its ownK133843 Saber Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation · 2014 · Recalled
Descendant · cites it directly · 6 of its ownK102645 Willow/Elm Pta Balloon Dilatation CatheterCreagh Medical, Ltd. · 2010
Descendant · 4 generations on · 4 of its ownK151153 Pirouette 018Arravasc Limited · 2015

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2009high 7 (2015) · low 0 (2018)2026

Most influential descendants

Showing 5 of 28 · See all

K083919Amphirion Deep 0.014 Otw Pta Balloon CatheterInvatec Innovative Technologies, S.R.L. · 2009 · cites it directly26descendants
K103464Pacific Xtreme Ptca Balloon Dilatation CatheterMedtronic, Inc. · 2010 · 2 generations on9descendants
K133843Saber Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation · 2014 · 3 generations on6descendants
K102645Willow/Elm Pta Balloon Dilatation CatheterCreagh Medical, Ltd. · 2010 · cites it directly6descendants
K151153Pirouette 018Arravasc Limited · 2015 · 4 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K050073	Modification to Amphirion Deep 0.014 Otw Pta Balloon Catheter	Invatec Innovative Technologies, S.R.L.	2005	—
+1	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
+3	K133843	Saber Percutaneous Transluminal Angioplasty Dilatation Catheter	Cordis Corporation	2014	1
+1	K102645	Willow/Elm Pta Balloon Dilatation Catheter	Creagh Medical, Ltd.	2010	—
+4	K151153	Pirouette 018	Arravasc Limited	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2010	3	0
2011	2	0
2012	1	0
2013	1	0
2014	1	0
2015	7	0
2016	2	0
2017	2	0
2019	1	0
2020	2	0
2021	1	0
2022	1	0
2023	1	0
2026	2	0

FIG. 1 — Lineage of K050073, 2005–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 DQY? 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 DQY device

#1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	—	currently marketed PTA balloon catheter Named without a submission number			—

What descends from it? (28)

See all 28

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K083919	Amphirion Deep 0.014 Otw Pta Balloon Catheter	Invatec Innovative Technologies, S.R.L.	2009	26
K102645	Willow/Elm Pta Balloon Dilatation Catheter	Creagh Medical, Ltd.	2010	6
K102705	Armada 14 Pta Catheter	Abbott Vascular, Inc.	2010	4
K142954	PTA 14 Balloon Dilatation Catheter OTW	Texasmedical Technologies, Inc.	2015	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 23, 2015	Class II	Z-0243-2016	Equipment maintenance	Medtronic has discovered that select lots of the Amphirion Deep PTA Balloon Dilation Catheter have a potential breach in the pouch seal enclosing the sterilized product.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K083919 (Invatec Innovative Technologies, S.R.L., 2009) has gone furthest, with 26 descendants of its own.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQY

21in 2025

2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007high 127 (2014) · low 66 (2008)2026

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

Recalls per year · DQY

1in 2025

2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, 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	16	85	6	313
2008	31	66	12	496
2009	37	73	17	819
2010	22	74	32	1,293
2011	36	71	6	1,211
2012	30	87	2	1,191
2013	32	92	36 (1)	1,352
2014	19	127	3	1,497
2015	27	118	3	2,337
2016	22	117	22 (7)	2,252
2017	26	113	8	2,489
2018	25	106	2	2,855
2019	30	111	1	2,902
2020	20	120	2	2,889
2021	18	81	2	3,006
2022	18	74	0	2,643
2023	18	114	17	3,049
2024	16	87	1	3,190
2025	21	115	1 (1)	3,056
2026	11	30	2 (1)	—

What is it indicated for?

The AMPHIRIONTM DEEP 0.014" OTW PTA Balloon Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, 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/K050073 · printed Nov 4, 2026

Cite this page

510(k) Report. “K050073: Modification to Amphirion Deep 0.014 Otw Pta Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050073

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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