510(k) · Cleared

Recalled · Class II · 2015

Amphirion Deep 0.014 Otw Pta Balloon Catheter

K042624510(k) TraditionalCleared Jan 10, 2005105-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 Jan 10, 2005 after a 105-day review. The FDA summary names its predicate without a number. 99 later devices descend from it. It has been recalled once.

Decided: Jan 10, 2005
Review: 105 days
Class: Class II
Product code: DQY
Recalls: 1
Predicates: 0

99 later devices descend from it, 5 citing it directly.

This deviceK042624 Amphirion Deep 0.014 Otw Pta Balloon CatheterInvatec Innovative Technologies, S.R.L. · 2005
Descendant · cites it directly · 52 of its ownK063657 Vascutrak Pta Dilation CatheterYmed, Inc. · 2006
Descendant · 2 generations on · 48 of its ownK073025 Vascutrak II Pta Dilatation CatheterThermopeutix, Inc. Dba Ymed, Inc. · 2007
Descendant · 3 generations on · 47 of its ownK082343 Vascutrak 2, Models: V14 and V18Ymed, Inc. · 2008
Descendant · 4 generations on · 36 of its ownK103459 Vascutrak Pta Dilatation CatheterC.R. Bard, Inc. · 2010
Descendant · 2 generations on · 32 of its ownK100303 Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy…Angioscore, Inc. · 2010

Showing 5 of 99 descendants. See all descendants

Descendants cleared per year

2005high 9 (2015) · low 1 (2023)2026

Most influential descendants

Showing 5 of 99 · See all

K063657Vascutrak Pta Dilation CatheterYmed, Inc. · 2006 · cites it directly52descendants
K073025Vascutrak II Pta Dilatation CatheterThermopeutix, Inc. Dba Ymed, Inc. · 2007 · 2 generations on48descendants
K082343Vascutrak 2, Models: V14 and V18Ymed, Inc. · 2008 · 3 generations on47descendants
K103459Vascutrak Pta Dilatation CatheterC.R. Bard, Inc. · 2010 · 4 generations on36descendants
K100303Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy, 2092-Xxyy, 2105-XxyyAngioscore, Inc. · 2010 · 2 generations on32descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K042624	Amphirion Deep 0.014 Otw Pta Balloon Catheter	Invatec Innovative Technologies, S.R.L.	2005	—
+1	K063657	Vascutrak Pta Dilation Catheter	Ymed, Inc.	2006	—
+2	K073025	Vascutrak II Pta Dilatation Catheter	Thermopeutix, Inc. Dba Ymed, Inc.	2007	—
+3	K082343	Vascutrak 2, Models: V14 and V18	Ymed, Inc.	2008	—
+4	K103459	Vascutrak Pta Dilatation Catheter	C.R. Bard, Inc.	2010	—
+2	K100303	Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy…	Angioscore, Inc.	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	2	0
2006	2	0
2007	3	0
2008	2	0
2009	4	0
2010	7	0
2011	7	0
2012	5	0
2013	3	0
2014	2	0
2015	9	0
2016	6	0
2017	7	0
2018	3	0
2019	3	0
2020	7	0
2021	5	0
2022	6	0
2023	1	0
2024	6	0
2025	3	0
2026	6	0

FIG. 1 — Lineage of K042624, 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? (2)

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
*	—	Boston Scientific SYMMIETRY Small Vessel Balloon Dilatation Catheter Named without a submission number			—
*	—	Cordis AVIATOR Peripheral Dilatation Catheter Named without a submission number			—

What descends from it? (99)

See all 99

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

Number	Device	Applicant	Decided	Descendants
K063657	Vascutrak Pta Dilation Catheter	Ymed, Inc.	2006	52
K083919	Amphirion Deep 0.014 Otw Pta Balloon Catheter	Invatec Innovative Technologies, S.R.L.	2009	26
K050276	Diver C.E. Catheter	Invatec Innovative Technologies, S.R.L.	2005	17
K102645	Willow/Elm Pta Balloon Dilatation Catheter	Creagh Medical, Ltd.	2010	6
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, K063657 (Ymed, Inc., 2006) has gone furthest, with 52 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 AMPHIRION™ 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/K042624 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042624: 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 6, 2026. https://510kreport.com/device/K042624

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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