510(k) · Cleared

Cleared

Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®)

K230374510(k) TraditionalCleared Jun 29, 2023136-day reviewClass II21 CFR 870.5100

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

Dongguan TT Medical, Inc. · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

Cleared on Jun 29, 2023 as substantially equivalent to K103808 (Orbusneich Medical, Inc., 2011) after a 136-day review. Its family tree reaches back 2 generations to 1980.

Decided: Jun 29, 2023
Review: 136 days
Class: Class II
Product code: LOX
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to P790017 (1980). 5 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backP790017 Usci Dilatation CatheterMedtronic, Ireland · 1980
1 generation backK103808 Sapphire NCOrbusneich Medical, Inc. · 2011
This deviceK230374 Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary…Dongguan TT Medical, Inc. · 2023

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	P790017	Usci Dilatation Catheter	Medtronic, Ireland	1980	—
−1	K103808	Sapphire NC	Orbusneich Medical, Inc.	2011	—
0 (this device)	K230374	Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation…	Dongguan TT Medical, Inc.	2023	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1982	1	0
1986	1	0
1988	1	0

FIG. 1 — Lineage of K230374, 1980–2023Source: 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 LOX? 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 LOX device

#1 K254022 FLASH Flex™ Aorto-Ostial Angioplasty Systemscore 12.3 · 5 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
*	K103808	Sapphire NC Summary page 4 …0(k) Number: K220279 3. Predicate Device Information Predicate Device: Sapphire® NC Coronary Dilatation Catheter (K103808, cleared August 9, 2011) Reference Device 1: Mozec TM NC-Rx PTCA Balloon Dilatation Cather…	Orbusneich Medical, Inc.	2011	—
†	K160961	Mozec NC-Rx PTCA Baloon Dilatation Catheter	Meril Life Sciences Private Limited	2016	—
†	K112735	Tamarin Blue Ptca RX Dilatation Catheter	Natec Medical, Ltd.	2012	—
†	K103657	Sapphire	Orbusneich Medical, Inc.	2011	—

Also cleared against K103808: 2 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 43 years and passes through 3 companies; a new generation was cleared every 31.4 years on median.
3 of the 5 ancestors have a recall of any class.
2 other devices also cite its predicate K103808.

How does its category compare?

All LOX devices

LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · LOX

4in 2024

2007high 32 (2010) · low 0 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LOX

241in 2024

2007high 241 (2024) · low 80 (2018)2026

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

Recalls per year · LOX

4in 2019

2007high 80 (2008) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LOX

1,890in 2025

2007high 2,753 (2017) · low 1,053 (2007)2025

MAUDE reports naming product code LOX, 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	19	—	1	1,053
2008	22	—	80	1,063
2009	28	—	0	1,353
2010	32	—	0	1,392
2011	9	103	0	2,090
2012	10	120	0	2,092
2013	6	123	0	2,436
2014	6	166	0	2,316
2015	4	119	0	2,060
2016	9	116	0	2,578
2017	6	113	0	2,753
2018	7	80	0	2,225
2019	1	—	4	2,102
2020	1	—	0	1,974
2021	6	167	0	1,738
2022	5	121	0	1,816
2023	4	138	0	1,720
2024	4	241	0	1,804
2025	0	—	0	1,890
2026	6	156	0	—

What is it indicated for?

The VesPenetrator®, VesTraveler® Coronary Dilatation Balloon Catheters are indicated for: • balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion • balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction The VexPander® Coronary Dilatation Balloon Catheters are indicated for: • balloon…

Read the full statement (114 words)

The VesPenetrator®, VesTraveler® Coronary Dilatation Balloon Catheters are indicated for:

• balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion

• balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction

The VexPander® Coronary Dilatation Balloon Catheters are indicated for:

• balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion

• balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction

• in-stent restenosis

• post-delivery expansion of balloon expandable coronary stents

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K230374 · printed Nov 6, 2026

Cite this page

510(k) Report. “K230374: Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230374

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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