510(k) · Cleared

Cleared

Ultraverse 014 and 018 Balloon Dilatation Catheters

K093965510(k) TraditionalCleared Mar 17, 201084-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

C.R. Bard, Inc. · LIT Catheter, Angioplasty, Peripheral, Transluminal

Cleared on Mar 17, 2010 as substantially equivalent to K012913 (C.R. Bard, Inc., 2001) after an 84-day review. Its family tree reaches back 1 generation to 2001. 15 later devices descend from it.

Decided: Mar 17, 2010
Review: 84 days
Class: Class II
Product code: LIT
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K012913 (2001). 15 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK012913 Bard Utaverse Small Vessel Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2001
This deviceK093965 Ultraverse 014 and 018 Balloon Dilatation CathetersC.R. Bard, Inc. · 2010
Descendant · cites it directly · 14 of its ownK121856 Ultraverse 014 and 018 Pta Balloon Dilatation Catheters Line ExtensionC.R. Bard, Inc. · 2012
Descendant · 2 generations on · 11 of its ownK131199 Ultraverse RX Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2013
Descendant · 3 generations on · 4 of its ownK150865 Metacross RX PTA Balloon Dilitation CatheterKANEKA Corporation · 2015
Descendant · 3 generations on · 3 of its ownK180921 Sapphire II PRO Balloon Dilatation CatheterOrbusneich Medical Trading, Inc. · 2018
Descendant · 2 generations on · 1 of its ownK192318 Ultraverse 014 and 018 PTA Balloon Dilatation CathetersBard Peripheral Vascular, Inc. · 2019

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2012high 3 (2016) · low 0 (2014)2026

Most influential descendants

Showing 5 of 15 · See all

K121856Ultraverse 014 and 018 Pta Balloon Dilatation Catheters Line ExtensionC.R. Bard, Inc. · 2012 · cites it directly14descendants
K131199Ultraverse RX Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2013 · 2 generations on11descendants
K150865Metacross RX PTA Balloon Dilitation CatheterKANEKA Corporation · 2015 · 3 generations on4descendants
K180921Sapphire II PRO Balloon Dilatation CatheterOrbusneich Medical Trading, Inc. · 2018 · 3 generations on3descendants
K192318Ultraverse 014 and 018 PTA Balloon Dilatation CathetersBard Peripheral Vascular, Inc. · 2019 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K012913	Bard Utaverse Small Vessel Pta Balloon Dilatation Catheter	C.R. Bard, Inc.	2001	—
0 (this device)	K093965	Ultraverse 014 and 018 Balloon Dilatation Catheters	C.R. Bard, Inc.	2010	—
+1	K121856	Ultraverse 014 and 018 Pta Balloon Dilatation Catheters Line Extension	C.R. Bard, Inc.	2012	—
+2	K131199	Ultraverse RX Pta Balloon Dilatation Catheter	Bard Peripheral Vascular, Inc.	2013	—
+3	K150865	Metacross RX PTA Balloon Dilitation Catheter	KANEKA Corporation	2015	—
+3	K180921	Sapphire II PRO Balloon Dilatation Catheter	Orbusneich Medical Trading, Inc.	2018	—
+2	K192318	Ultraverse 014 and 018 PTA Balloon Dilatation Catheters	Bard Peripheral Vascular, Inc.	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2013	1	0
2015	1	0
2016	3	0
2017	2	0
2018	1	0
2019	1	0
2020	2	0
2022	1	0
2023	1	0
2026	1	0

FIG. 1 — Lineage of K093965, 2001–2026Source: 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 LIT? 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 LIT device

#1 K241040 Amethyst HP PTA OTW 0.035 Catheterscore 13.9 · 9 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
*	K012913	Bard Utaverse Small Vessel Pta Balloon Dilatation Catheter Summary page 1 …vascular 3. Predicate Device: Device Trade Name: Ultraverse® Small Vessel PTA Balloon Dilatation Catheter Cleared 510(K) Number: K012913 Date of Cleared 510(K): 09/28/01 4. Summary of Change: The modifications from the predicate device, the Ul…	C.R. Bard, Inc.	2001	—

Also cleared against K012913: 1 other device →

What descends from it? (15)

See all 15

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K121856	Ultraverse 014 and 018 Pta Balloon Dilatation Catheters Line Extension	C.R. Bard, Inc.	2012	14

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?

Its one ancestor has no recall.
Of its descendants, K121856 (C.R. Bard, Inc., 2012) has gone furthest, with 14 descendants of its own.
1 other device also cites its predicate K012913.

How does its category compare?

All LIT devices

LIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · LIT

3in 2025

2007high 19 (2012) · low 3 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LIT

90in 2025

2007high 205 (2026) · low 29 (2009)2026

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

Recalls per year · LIT

1in 2025

2007high 3 (2014) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · LIT

2,073in 2025

2007high 2,492 (2021) · low 513 (2008)2025

MAUDE reports naming product code LIT, 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	6	64	0	577
2008	8	53	0	513
2009	7	29	2	623
2010	13	78	1	809
2011	10	82	0	857
2012	19	29	0	1,277
2013	14	79	2 (2)	1,242
2014	12	90	3	1,178
2015	19	112	0	1,279
2016	11	116	1	1,529
2017	9	57	0	2,081
2018	6	118	2	2,188
2019	4	40	3	2,405
2020	9	125	0	2,443
2021	4	61	1	2,492
2022	8	122	0	2,155
2023	6	167	0	1,807
2024	6	43	2	1,913
2025	3	90	1	2,073
2026	4	205	0	—

What is it indicated for?

The Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters are recommended for use in Percutaneous Translumninal Angioplasty of the renal. tibial, popiteal, femoral and peroneal arteries. These catheters are not for use in coronary arteries.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K093965 · printed Nov 6, 2026

Cite this page

510(k) Report. “K093965: Ultraverse 014 and 018 Balloon Dilatation Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093965

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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