510(k) · Cleared

Recalled · Class II · 2015

Amphirion Deep 0.014 Otw Pta Balloon Catheter

K083919510(k) TraditionalCleared Mar 13, 200972-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 Mar 13, 2009 as substantially equivalent to K042624 (Invatec Innovative Technologies, S.R.L., 2005) and 3 other predicates after a 72-day review. Its family tree reaches back 2 generations to 2004. 26 later devices descend from it. It has been recalled once.

Decided: Mar 13, 2009
Review: 72 days
Class: Class II
Product code: DQY
Recalls: 1
Predicates: 4

Its longest line of descent runs back 2 generations to K042537 (2004). 5 ancestors in all. 26 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 2 generations backK042537 Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter…Invatec Innovative Technologies · 2004
1 generation backK072947 Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta)…ClearStream Technologies, Ltd. · 2008
This deviceK083919 Amphirion Deep 0.014 Otw Pta Balloon CatheterInvatec Innovative Technologies, S.R.L. · 2009
Descendant · cites it directly · 9 of its ownK103464 Pacific Xtreme Ptca Balloon Dilatation CatheterMedtronic, Inc. · 2010 · Recalled
Descendant · 2 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 · 3 generations on · 4 of its ownK151153 Pirouette 018Arravasc Limited · 2015
Descendant · cites it directly · 4 of its ownK102705 Armada 14 Pta CatheterAbbott Vascular, Inc. · 2010

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2010high 6 (2015) · low 0 (2018)2026

Most influential descendants

Showing 5 of 26 · See all

K103464Pacific Xtreme Ptca Balloon Dilatation CatheterMedtronic, Inc. · 2010 · cites it directly9descendants
K133843Saber Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation · 2014 · 2 generations on6descendants
K102645Willow/Elm Pta Balloon Dilatation CatheterCreagh Medical, Ltd. · 2010 · cites it directly6descendants
K151153Pirouette 018Arravasc Limited · 2015 · 3 generations on4descendants
K102705Armada 14 Pta CatheterAbbott Vascular, Inc. · 2010 · cites it directly4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K042537	Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model…	Invatec Innovative Technologies	2004	—
−1	K072947	Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) Catheters	ClearStream Technologies, Ltd.	2008	—
0 (this device)	K083919	Amphirion Deep 0.014 Otw Pta Balloon Catheter	Invatec Innovative Technologies, S.R.L.	2009	—
+1	K103464	Pacific Xtreme Ptca Balloon Dilatation Catheter	Medtronic, Inc.	2010	1
+2	K133843	Saber Percutaneous Transluminal Angioplasty Dilatation Catheter	Cordis Corporation	2014	1
+1	K102645	Willow/Elm Pta Balloon Dilatation Catheter	Creagh Medical, Ltd.	2010	—
+3	K151153	Pirouette 018	Arravasc Limited	2015	—
+1	K102705	Armada 14 Pta Catheter	Abbott Vascular, Inc.	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2005	3	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	3	0
2011	2	0
2012	1	0
2013	1	0
2014	1	0
2015	6	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 K083919, 2004–2026Source: 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? (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	Applicant	Decided	Recalls
*	K042624	Amphirion Deep 0.014 Otw Pta Balloon Catheter Summary page 1 …minal Angioplasty Catheter Regulation Name: Percutaneous Catheter Predicate Devices * Invatec AMPHIRION DEEP 0.014" OTW PTA Balloon Dilatation Catheters (K042624, K050073 & K052791) * Clearstream Technologies SLEEK PTA Catheter (K072947) Device Description The AMPHIRION DEEP 0.014" OTW…	Invatec Innovative Technologies, S.R.L.	2005	1
*	K050073	Modification to Amphirion Deep 0.014 Otw Pta Balloon Catheter Summary page 1 …ioplasty Catheter Regulation Name: Percutaneous Catheter Predicate Devices * Invatec AMPHIRION DEEP 0.014" OTW PTA Balloon Dilatation Catheters (K042624, K050073 & K052791) * Clearstream Technologies SLEEK PTA Catheter (K072947) Device Description The AMPHIRION DEEP 0.014" OTW PTA Ballo…	Invatec Innovative Technologies, S.R.L.	2005	1
*	K052791	Modification to: Amphirion Deep 0.014 Otw Pta Balloon Catheter Summary page 1 …atheter Regulation Name: Percutaneous Catheter Predicate Devices * Invatec AMPHIRION DEEP 0.014" OTW PTA Balloon Dilatation Catheters (K042624, K050073 & K052791) * Clearstream Technologies SLEEK PTA Catheter (K072947) Device Description The AMPHIRION DEEP 0.014" OTW PTA Balloon Dilatat…	Invatec Innovative Technologies, S.R.L.	2005	1
*	K072947	Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) Catheters Summary page 1 …ate Devices * Invatec AMPHIRION DEEP 0.014" OTW PTA Balloon Dilatation Catheters (K042624, K050073 & K052791) * Clearstream Technologies SLEEK PTA Catheter (K072947) Device Description The AMPHIRION DEEP 0.014" OTW PTA Balloon Dilatation Catheter is an over-the- wire percutaneous transluminal…	ClearStream Technologies, Ltd.	2008	—

Also cleared against K042624: 4 other devices →

What descends from it? (26)

See all 26

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

Number	Device	Applicant	Decided	Descendants
K103464	Pacific Xtreme Ptca Balloon Dilatation Catheter	Medtronic, Inc.	2010	9
K102645	Willow/Elm Pta Balloon Dilatation Catheter	Creagh Medical, Ltd.	2010	6
K102705	Armada 14 Pta Catheter	Abbott Vascular, Inc.	2010	4
K112513	Ebony Pta 0.014 Peripheral Dilatation Catheter	Natec Medical, Ltd.	2011	3
K123358	Pacific Plus	Medtronic Vascular	2013	1

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?

The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
3 of the 5 ancestors have a recall of any class.
Of its descendants, K103464 (Medtronic, Inc., 2010) has gone furthest, with 9 descendants of its own.
4 other devices also cite its predicate K042624.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

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 AMPHIRION DEEP 0.014" OTW PTA Balloon Dilatation Catheters, with 150 mm and 210 mm balloon lengths, are intended to dilate stenoses in the femoral, popliteal, and infra-popliteal arteries.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K083919 · printed Nov 5, 2026

Cite this page

510(k) Report. “K083919: 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 5, 2026. https://510kreport.com/device/K083919

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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