510(k) · Cleared
ClearedV8 Transluminal BAV Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intervalve, Inc. · OZT Balloon Aortic Valvuloplasty
Cleared on Apr 3, 2015 as substantially equivalent to K133607 (Intervalve, Inc., 2014) and 1 other predicate after a 51-day review. Its family tree reaches back 4 generations to 2012. 1 later device descends from it.
- Decided
- Apr 3, 2015
- Review
- 51 days
- Class
- Class II
- Product code
- OZT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to DEN080015 (2012). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backDEN080015 Nucleus-X PTV CatheterNuMED, Inc. · 2012
- 3 generations backK123111 V8 Transluminal Bav CatheterIntervalve, Inc. · 2013
- 2 generations backK132728 V8 Transluminal Bav CatheterIntervalve, Inc. · 2013
- 1 generation backK133607 V8 Transluminal Bav CatheterIntervalve, Inc. · 2014 · Recalled
- This deviceK150343 V8 Transluminal BAV CatheterIntervalve, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK152150 V8 Balloon Aortic Valvuloplasty CatheterIntervalve, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K152150V8 Balloon Aortic Valvuloplasty CatheterIntervalve, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN080015 | Nucleus-X PTV Catheter | NuMED, Inc. | 2012 | — |
| −3 | K123111 | V8 Transluminal Bav Catheter | Intervalve, Inc. | 2013 | — |
| −2 | K132728 | V8 Transluminal Bav Catheter | Intervalve, Inc. | 2013 | — |
| −1 | K133607 | V8 Transluminal Bav Catheter | Intervalve, Inc. | 2014 | 1 |
| 0 (this device) | K150343 | V8 Transluminal BAV Catheter | Intervalve, Inc. | 2015 | — |
| +1 | K152150 | V8 Balloon Aortic Valvuloplasty Catheter | Intervalve, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 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 K253855 KardiaPSI Balloon Catheterscore 11.3 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K133607 | V8 Transluminal Bav CatheterSummary page 5…5 PREDICATE DEVICE The modified device is substantially equivalent to the InterValve V8 Transluminal BAV Catheter (K133607) and the Z-Med/Z-Med II (K122012). DEVICE DESCRIPTION The V8 Transluminal BAV Catheter System features an hour glass s… | 2014 |
| * | K122012 | Z-Med Z-Med IISummary page 5…PREDICATE DEVICE The modified device is substantially equivalent to the InterValve V8 Transluminal BAV Catheter (K133607) and the Z-Med/Z-Med II (K122012). DEVICE DESCRIPTION The V8 Transluminal BAV Catheter System features an hour glass shaped dilatation balloon on the d… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152150 | V8 Balloon Aortic Valvuloplasty Catheter | 2015 | 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?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 10 months on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K152150 (Intervalve, Inc., 2015) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OZT devicesOZT Balloon Aortic Valvuloplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · OZT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OZT
115in 2015
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
MAUDE reports naming product code OZT, 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 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 3 | — | 0 | 0 |
| 2013 | 3 | 80 | 0 | 29 |
| 2014 | 4 | 79 | 0 | 17 |
| 2015 | 4 | 115 | 0 | 16 |
| 2016 | 1 | — | 0 | 9 |
| 2017 | 1 | — | 0 | 38 |
| 2018 | 0 | — | 0 | 31 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 11 |
| 2021 | 0 | — | 0 | 18 |
| 2022 | 1 | — | 0 | 33 |
| 2023 | 1 | — | 0 | 47 |
| 2024 | 1 | — | 0 | 38 |
| 2025 | 1 | — | 0 | 34 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The V8 Transluminal BAV Catheter is indicated for Balloon Aortic Valvuloplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150343 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150343: V8 Transluminal BAV Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150343
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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