510(k) · Cleared

Cleared

Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model Suvxxxxxxxxx

K042537510(k) TraditionalCleared Nov 8, 200449-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

Invatec Innovative Technologies · DQY Catheter, Percutaneous

Cleared on Nov 8, 2004 after a 49-day review. The FDA summary names its predicate without a number. 99 later devices descend from it.

Decided: Nov 8, 2004
Review: 49 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 0

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

This deviceK042537 Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter…Invatec Innovative Technologies · 2004
Descendant · cites it directly · 79 of its ownK072947 Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta)…ClearStream Technologies, Ltd. · 2008
Descendant · 2 generations on · 35 of its ownK082579 Evercross .035 Otw Pta Dilatation CatheterEv3, Inc. · 2008 · Recalled
Descendant · 2 generations on · 26 of its ownK083919 Amphirion Deep 0.014 Otw Pta Balloon CatheterInvatec Innovative Technologies, S.R.L. · 2009 · Recalled
Descendant · cites it directly · 17 of its ownK050276 Diver C.E. CatheterInvatec Innovative Technologies, S.R.L. · 2005 · Recalled
Descendant · 3 generations on · 14 of its ownK093286 Powercross .018 Otw Pta Dilation CatheterEv3, Inc. · 2009 · Recalled

Showing 5 of 99 descendants. See all descendants

Descendants cleared per year

2005high 10 (2016) · low 1 (2006)2026

Most influential descendants

Showing 5 of 99 · See all

K072947Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) CathetersClearStream Technologies, Ltd. · 2008 · cites it directly79descendants
K082579Evercross .035 Otw Pta Dilatation CatheterEv3, Inc. · 2008 · 2 generations on35descendants
K083919Amphirion Deep 0.014 Otw Pta Balloon CatheterInvatec Innovative Technologies, S.R.L. · 2009 · 2 generations on26descendants
K050276Diver C.E. CatheterInvatec Innovative Technologies, S.R.L. · 2005 · cites it directly17descendants
K093286Powercross .018 Otw Pta Dilation CatheterEv3, Inc. · 2009 · 3 generations on14descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	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	—
+2	K082579	Evercross .035 Otw Pta Dilatation Catheter	Ev3, Inc.	2008	1
+2	K083919	Amphirion Deep 0.014 Otw Pta Balloon Catheter	Invatec Innovative Technologies, S.R.L.	2009	1
+1	K050276	Diver C.E. Catheter	Invatec Innovative Technologies, S.R.L.	2005	1
+3	K093286	Powercross .018 Otw Pta Dilation Catheter	Ev3, Inc.	2009	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	2	0
2006	1	0
2007	2	0
2008	3	0
2009	7	0
2010	8	0
2011	9	0
2012	7	0
2013	7	0
2014	3	0
2015	8	0
2016	10	0
2017	6	0
2018	2	0
2019	3	0
2020	6	0
2021	4	0
2022	4	0
2023	1	0
2024	1	0
2025	1	0
2026	4	0

FIG. 1 — Lineage of K042537, 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

Get a 510(k) Report

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
*	—	Cordis SAVVY Balloon Dilatation Catheter Named without a submission number			—

What descends from it? (99)

See all 99

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

Number	Device	Applicant	Decided	Descendants
K072947	Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) Catheters	ClearStream Technologies, Ltd.	2008	79
K050276	Diver C.E. Catheter	Invatec Innovative Technologies, S.R.L.	2005	17
K103464	Pacific Xtreme Ptca Balloon Dilatation Catheter	Medtronic, Inc.	2010	9
K121265	Amphirion Plus Pta Catheter	Medtronic, Inc.	2012	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?

Of its descendants, K072947 (ClearStream Technologies, Ltd., 2008) has gone furthest, with 79 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 SUBMARINE™ PLUS Balloon Dilatation 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/K042537 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042537: Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model Suvxxxxxxxxx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042537

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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