V8 TRANSLUMINAL BAV CATHETER— 510(k) K132728

Name: FDA 510(k) clearance K132728
Creator: U.S. Food and Drug Administration
Published: 2013-11-22

Substantially Equivalent

Intervalve, Inc.

FDA 510(k) clearance K132728 for V8 TRANSLUMINAL BAV CATHETER, Substantially Equivalent on 2013-11-22. Applicant: Intervalve, Inc.. Device class: 2.

Clearance details

Applicant: Intervalve, Inc.
Product code: Code OZT
Device class: Class 2
Regulation: 21 CFR 870.1255
Advisory panel: Cardiovascular
Date received: 2013-09-03
Decision date: 2013-11-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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K240967 — ValvuloPro Valvuloplasty Balloon Catheter2024-07-31
K231814 — ValvuloPro Valvuloplasty Balloon Catheter2023-10-12

More clearances from Intervalve, Inc.

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K152150 — V8 Balloon Aortic Valvuloplasty Catheter2015-12-18
K150343 — V8 Transluminal BAV Catheter2015-04-03
K133607 — V8 TRANSLUMINAL BAV CATHETER2014-02-11
K123111 — V8 TRANSLUMINAL BAV CATHETER2013-01-31

Adverse events under product code OZT

product code OZT

Death: 20
Other: 2
Total: 22

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.