510(k) Report

510(k) · Cleared

Cleared

True Dilatation Balloon Valvuloplasty Catheter, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM

K133569510(k) SpecialCleared Dec 20, 201330-day reviewClass II21 CFR 870.1255

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

Bard Peripheral Vascular, Inc. · OZT Balloon Aortic Valvuloplasty

Cleared on Dec 20, 2013 as substantially equivalent to K121083 (Loma Vista Medical, 2012) after a 30-day review. Its family tree reaches back 1 generation to 2012. 9 later devices descend from it.

Decided
Dec 20, 2013
Review
30 days
Class
Class II
Product code
OZT
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K121083 (2012). 9 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2014: 1 descendant cleared2015: 2 descendants cleared2022: 1 descendant cleared2016: 1 descendant cleared2017: 1 descendant cleared2024: 1 descendant cleared2025: 2 descendants clearedK121083 · True Dilatation Percutaneous Transluminal Valvuloplasty Catheter, 20MM X 4.5CM, True Dilatation Percutaneous Translumina · Loma Vista Medical · 2012 · recalled2010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 2 descendants K121083 · True Dilatation Percutaneous Transluminal Valvuloplasty Catheter, 20MM X 4.5CM, True Dilatation Percutaneous Translumina · Loma Vista Medical · 2012 · recalled0
  1. Root · 1 generation backK121083 True Dilatation Percutaneous Transluminal Valvuloplasty Catheter…Loma Vista Medical · 2012 · Recalled
  2. This deviceK133569 True Dilatation Balloon Valvuloplasty Catheter, 20MM X 4.5 CM, 22MM…Bard Peripheral Vascular, Inc. · 2013
  3. Descendant · cites it directly · 3 of its ownK142083 True Flow Valvuloplasty Perfusion CatheterC.R. Bard, Inc. · 2015
  4. Descendant · cites it directly · 3 of its ownK141985 True BA V Balloon Valvuloplasty CatheterC.R. Bard, Inc. · 2014
  5. Descendant · 2 generations on · 2 of its ownK212588 Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation…C.R. Bard, Inc. · 2022
  6. Descendant · 2 generations on · 2 of its ownK152613 True Flow Valvuloplasty Perfusion CatheterC.R. Bard, Inc. · 2016
  7. Descendant · 3 generations on · 1 of its ownK241040 Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd. · 2024

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2014: 12015: 22016: 12017: 12022: 12024: 12025: 2
2014high 2 (2015) · low 0 (2018)2026

Most influential descendants

Showing 5 of 9 · See all
  • K142083True Flow Valvuloplasty Perfusion CatheterC.R. Bard, Inc. · 2015 · cites it directly3descendants
  • K141985True BA V Balloon Valvuloplasty CatheterC.R. Bard, Inc. · 2014 · cites it directly3descendants
  • K212588Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV…C.R. Bard, Inc. · 2022 · 2 generations on2descendants
  • K152613True Flow Valvuloplasty Perfusion CatheterC.R. Bard, Inc. · 2016 · 2 generations on2descendants
  • K241040Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd. · 2024 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K121083True Dilatation Percutaneous Transluminal Valvuloplasty Catheter, 20MM X…Loma Vista Medical20121
0 (this device)K133569True Dilatation Balloon Valvuloplasty Catheter, 20MM X 4.5 CM, 22MM X 4.5CM…Bard Peripheral Vascular, Inc.2013—
+1K142083True Flow Valvuloplasty Perfusion CatheterC.R. Bard, Inc.2015—
+1K141985True BA V Balloon Valvuloplasty CatheterC.R. Bard, Inc.2014—
+2K212588Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida…C.R. Bard, Inc.2022—
+2K152613True Flow Valvuloplasty Perfusion CatheterC.R. Bard, Inc.2016—
+3K241040Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd.2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201520
201610
201710
202210
202410
202520
FIG. 1 — Lineage of K133569, 2012–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 OZT? 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 OZT device

  1. #1 K253855 KardiaPSI Balloon Catheterscore 11.3 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K121083True Dilatation Percutaneous Transluminal Valvuloplasty Catheter, 20MM X 4.5CM, True…
Summary page 1
…0 Product Code: OZT Predicate Device(s): The subject device is equivalent to the following devices: " True Dilatation Balloon Valvuloplasty Catheter, 510(k) number K121083 Device Description: The True Dilatation Catheter is a coaxial catheter with a balloon fixed at the tip used for Balloon Aortic…
Loma Vista Medical20121

Also cleared against K121083: 2 other devices →

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K142083True Flow Valvuloplasty Perfusion CatheterC.R. Bard, Inc.20153
K141985True BA V Balloon Valvuloplasty CatheterC.R. Bard, Inc.20143
K150667True Dilatation Balloon Valvuloplasty CatheterC.R. Bard, Inc.20150

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 a recall.
  • Of its descendants, K142083 (C.R. Bard, Inc., 2015) has gone furthest, with 3 descendants of its own.
  • 2 other devices also cite its predicate K121083.

How does its category compare?

All OZT devices

OZT Balloon Aortic Valvuloplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · OZT

1in 2025

2012: 32013: 32014: 42015: 42016: 12017: 12022: 12023: 12024: 12025: 12026 (partial year): 2
2007high 4 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OZT

115in 2015

2013: 80 days median2014: 79 days median2015: 115 days median
2007high 115 (2015) · low 79 (2014)2026

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

Recalls per year · OZT

No recall names OZT since 2007.

Adverse event reports per year · OZT

34in 2025

2013: 292014: 172015: 162016: 92017: 382018: 312019: 102020: 112021: 182022: 332023: 472024: 382025: 34
2007high 47 (2023) · low 0 (2007)2025

MAUDE reports naming product code OZT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20123—00
2013380029
2014479017
20154115016
20161—09
20171—038
20180—031
20190—010
20200—011
20210—018
20221—033
20231—047
20241—038
20251—034
20262—0—

What is it indicated for?

The True Dilatation Balloon Valvuloplasty Catheter is indicated for balloon aortic valvuloplasty.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K121083

2 other devices cite the same predicate.

  • K142199Ascendra Balloon Aortic Valvaloplasty CatheterEdwards Lifesciences · 2014
  • K140241Edwards Transfemoral Balloon CatheterEdwards Lifesciences, LLC · 2014

More from Bard Peripheral Vascular, Inc.

174 FDA decisions under this applicant name. See the company

  • P250050/S001Liverty™ TIPS Stent GraftBard Peripheral Vascular, Inc. · 2026
  • P250050Liverty™ TIPS Stent GraftBard Peripheral Vascular, Inc. · 2026
  • K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc. · 2026
  • P130029/S015Fluency™ Plus Endovascular Stent GraftBard Peripheral Vascular, Inc. · 2026
  • P070014/S069LifeStent™ 5F Vascular Stent SystemsBard Peripheral Vascular, Inc. · 2026

Recent decisions in OZT

The OZT category page

  • K253855KardiaPSI Balloon CatheterIntervention Tech, Inc. ; dba Corvention · 2026
  • K260437Valvuloplasty Balloon Catheter (ValvuloPro)Dongguan TT Medical, Inc. · 2026
  • K241562OutFlo Aortic Valve Dilatation Balloon CatheterDisa Medinotec · 2025
  • K240967ValvuloPro Valvuloplasty Balloon CatheterDongguan TT Medical, Inc. · 2024
  • K231814ValvuloPro Valvuloplasty Balloon CatheterDongguan TT Medical, Inc. · 2023

https://510kreport.com/device/K133569 · printed Nov 4, 2026

Cite this page

510(k) Report. “K133569: True Dilatation Balloon Valvuloplasty Catheter, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133569

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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