510(k) · Cleared
ClearedVida PTV Dilataton Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · OMZ Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter
Cleared on Jul 2, 2013 as substantially equivalent to K122367 (C.R. Bard, Inc., 2012) and 1 other predicate after an 83-day review. Its family tree reaches back 6 generations to 1993. 4 later devices descend from it.
- Decided
- Jul 2, 2013
- Review
- 83 days
- Class
- Class II
- Product code
- OMZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K933483 (1993). 12 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK933483 Opti-Plast 5F Pta CathetersVas-Cath, Inc. · 1993
- 5 generations backK973013 Opti-Plast (Centurion) 5.5F Angioplasty CatheterVas-Cath, Inc. · 1998
- 4 generations backK040243 Bard Atlas Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2004
- 3 generations backK052236 Bard Atlas Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2005
- 2 generations backK120971 Atlas Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2012
- 1 generation backK122984 Atlas Gold Pta Dilatation CatheterC.R. Bard, Inc. · 2012
- This deviceK131002 Vida PTV Dilataton CatheterC.R. Bard, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK141985 True BA V Balloon Valvuloplasty CatheterC.R. Bard, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK212588 Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation…C.R. Bard, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK241040 Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK251915 Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd. · 2025
Most influential descendants
Showing 4 of 4 · See all- 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 · cites it directly2descendants
- K241040Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd. · 2024 · 2 generations on1descendant
- K251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K933483 | Opti-Plast 5F Pta Catheters | Vas-Cath, Inc. | 1993 | — |
| −5 | K973013 | Opti-Plast (Centurion) 5.5F Angioplasty Catheter | Vas-Cath, Inc. | 1998 | — |
| −4 | K040243 | Bard Atlas Pta Balloon Dilatation Catheter | C.R. Bard, Inc. | 2004 | — |
| −3 | K052236 | Bard Atlas Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2005 | — |
| −2 | K120971 | Atlas Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2012 | — |
| −1 | K122984 | Atlas Gold Pta Dilatation Catheter | C.R. Bard, Inc. | 2012 | — |
| 0 (this device) | K131002 | Vida PTV Dilataton Catheter | C.R. Bard, Inc. | 2013 | — |
| +1 | K141985 | True BA V Balloon Valvuloplasty Catheter | C.R. Bard, Inc. | 2014 | — |
| +1 | K212588 | Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida… | C.R. Bard, Inc. | 2022 | — |
| +2 | K241040 | Amethyst HP PTA OTW 0.035 Catheter | Natec Medical, Ltd. | 2024 | — |
| +3 | K251915 | Amethyst HP PTA OTW 0.035 Catheter | Natec Medical, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2002 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
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 OMZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 | Decided |
|---|---|---|---|
| * | K122367 | Bard PTV Dilatation CatheterSummary page 1…OMZ) Classification: Class 11 Classification Panel: Cardiovascular Predicate Devices: *Bard PTV Dilatation Catheter (K1 22367; cleared November 2, 2012) *Atlas Gold PTA Dilatation Catheter (K1 22984, cleared October 22, 2012) Bard Peripheral V… | 2012 |
| * | K122984 | Atlas Gold Pta Dilatation CatheterSummary page 1…Cardiovascular Predicate Devices: *Bard PTV Dilatation Catheter (K1 22367; cleared November 2, 2012) *Atlas Gold PTA Dilatation Catheter (K1 22984, cleared October 22, 2012) Bard Peripheral Vascular, Inc. =I… | 2012 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 20 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K141985 (C.R. Bard, Inc., 2014) has gone furthest, with 3 descendants of its own.
How does its category compare?
All OMZ devicesOMZ Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · OMZ
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · OMZ
Too few OMZ 510(k)s in any year since 2007 to give a median.
Recalls per year · OMZ
No recall names OMZ since 2007.
Adverse event reports per year · OMZ
3in 2024
MAUDE reports naming product code OMZ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Vida PTV Dilatation Catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve in the following:
* A patient with isolated pulmonary valve stenosis
* A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131002 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131002: Vida PTV Dilataton Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131002
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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