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 Nov 22, 2013 as substantially equivalent to K123111 (Intervalve, Inc., 2013) and 1 other predicate after an 80-day review. Its family tree reaches back 2 generations to 2012. 3 later devices descend from it.
- Decided
- Nov 22, 2013
- Review
- 80 days
- Class
- Class II
- Product code
- OZT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to DEN080015 (2012). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backDEN080015 Nucleus-X PTV CatheterNuMED, Inc. · 2012
- 1 generation backK123111 V8 Transluminal Bav CatheterIntervalve, Inc. · 2013
- This deviceK132728 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 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN080015 | Nucleus-X PTV Catheter | NuMED, Inc. | 2012 | — |
| −1 | K123111 | V8 Transluminal Bav Catheter | Intervalve, Inc. | 2013 | — |
| 0 (this device) | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K123111 | V8 Transluminal Bav CatheterSummary page 2…ter is packaged in a heat sealed Tyvek pouch and provided sterilized. It is intended for single use only. These characteristics are identical to the predicate V8 device (K 123 111). 1.7 PERFORMANCE DATA The relevant design verification testing was repeated. These tests included all bonds and balloon chara… | 2013 |
| * | 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? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133607 | V8 Transluminal Bav Catheter | 2014 | 2 |
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 1 year and passes through 2 companies; a new generation was cleared every 10 months on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K133607 (Intervalve, Inc., 2014) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K123111.
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 V8 Translumninal BAV Catheter is indicated for Balloon Aortic Valviiioplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132728 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132728: 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/K132728
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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