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 Jan 31, 2013 as substantially equivalent to DEN080015 (NuMED, Inc., 2012) after a 120-day review. Its family tree reaches back 1 generation to 2012. 4 later devices descend from it.
- Decided
- Jan 31, 2013
- Review
- 120 days
- Class
- Class II
- Product code
- OZT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN080015 (2012). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backDEN080015 Nucleus-X PTV CatheterNuMED, Inc. · 2012
- This deviceK123111 V8 Transluminal Bav CatheterIntervalve, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK132728 V8 Transluminal Bav CatheterIntervalve, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK133607 V8 Transluminal Bav CatheterIntervalve, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 1 of its ownK150343 V8 Transluminal BAV CatheterIntervalve, Inc. · 2015
- Descendant · 3 generations on · 0 of its ownK152150 V8 Balloon Aortic Valvuloplasty CatheterIntervalve, Inc. · 2015
Most influential descendants
Showing 4 of 4 · See all- K132728V8 Transluminal Bav CatheterIntervalve, Inc. · 2013 · cites it directly3descendants
- K133607V8 Transluminal Bav CatheterIntervalve, Inc. · 2014 · cites it directly2descendants
- K150343V8 Transluminal BAV CatheterIntervalve, Inc. · 2015 · 2 generations on1descendant
- K152150V8 Balloon Aortic Valvuloplasty CatheterIntervalve, Inc. · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN080015 | Nucleus-X PTV Catheter | NuMED, Inc. | 2012 | — |
| 0 (this device) | K123111 | V8 Transluminal Bav Catheter | Intervalve, Inc. | 2013 | — |
| +1 | K132728 | V8 Transluminal Bav Catheter | Intervalve, Inc. | 2013 | — |
| +1 | K133607 | V8 Transluminal Bav Catheter | Intervalve, Inc. | 2014 | 1 |
| +2 | K150343 | V8 Transluminal BAV Catheter | Intervalve, Inc. | 2015 | — |
| +3 | K152150 | V8 Balloon Aortic Valvuloplasty Catheter | Intervalve, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 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 |
|---|---|---|---|
| * | DEN080015 | Nucleus-X PTV Catheter Our reading of the summary gave K082776, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN080015, Nucleus-X PTV Catheter (NuMED, Inc.), granted Jun 11, 2012; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 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?
How does its category compare?
All OZT devicesOZT 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
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 VS Translumninal BAV Catheter is indicated for Balloon Aortic Valvuloplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123111 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123111: 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/K123111
Report an extraction error
Are you the manufacturer?
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