510(k) · Cleared
ClearedV8 Balloon Aortic Valvuloplasty 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 Dec 18, 2015 as substantially equivalent to K150343 (Intervalve, Inc., 2015) after a 137-day review. Its family tree reaches back 5 generations to 2012.
- Decided
- Dec 18, 2015
- Review
- 137 days
- Class
- Class II
- Product code
- OZT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN080015 (2012). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backDEN080015 Nucleus-X PTV CatheterNuMED, Inc. · 2012
- 4 generations backK123111 V8 Transluminal Bav CatheterIntervalve, Inc. · 2013
- 3 generations backK132728 V8 Transluminal Bav CatheterIntervalve, Inc. · 2013
- 2 generations backK133607 V8 Transluminal Bav CatheterIntervalve, Inc. · 2014 · Recalled
- 1 generation backK150343 V8 Transluminal BAV CatheterIntervalve, Inc. · 2015
- This deviceK152150 V8 Balloon Aortic Valvuloplasty CatheterIntervalve, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN080015 | Nucleus-X PTV Catheter | NuMED, Inc. | 2012 | — |
| −4 | K123111 | V8 Transluminal Bav Catheter | Intervalve, Inc. | 2013 | — |
| −3 | K132728 | V8 Transluminal Bav Catheter | Intervalve, Inc. | 2013 | — |
| −2 | K133607 | V8 Transluminal Bav Catheter | Intervalve, Inc. | 2014 | 1 |
| −1 | K150343 | V8 Transluminal BAV Catheter | Intervalve, Inc. | 2015 | — |
| 0 (this device) | 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 |
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? (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 | Decided |
|---|---|---|---|
| * | K150343 | V8 Transluminal BAV CatheterSummary page 5…ated to None Modified Device 1.2. PREDICATE DEVICE The modified device is substantially equivalent to the InterValve V8 Transluminal BAV Catheter (K150343). 1.3. DEVICE DESCRIPTION The V8 Balloon Aortic Valvuloplasty Catheter features an hour glass shaped dilatation balloon on th… | 2015 |
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 3 years and passes through 2 companies; a new generation was cleared every 9 months on median.
- 1 of the 6 ancestors has a recall of any class.
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 Balloon Aortic Valvuloplasty Catheter is indicated for Balloon Aortic Valvuloplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152150 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152150: V8 Balloon Aortic Valvuloplasty Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152150
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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