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V8 Transluminal Balloon Aortic Valvuloplasty Catheter

by Intervalve, Inc. 4 variants

510(k) K132728

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK132728 Date22 Nov 2013ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
V8 Transluminal Bav Catheter
510(k) Number
FDA Product Code
OZT
Device Class
Class II
Regulation
21 CFR Part 870.1255
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The V8 Transluminal Balloon Aortic Valvuloplasty Catheter is a Balloon Aortic Valvuloplasty device, designed to mechanically dilate a stenotic aortic valve via transluminal balloon inflation. It is intended for use in percutaneous interventions to improve blood flow through a narrowed aortic valve, typically in patients with aortic stenosis.

This catheter is supplied as a single-use, sterile device and is classified as a Class 2 medical device under FDA regulations (product code OZT). It is cleared through the FDA 510(k) pathway and is intended for use in controlled clinical settings, such as cardiac catheterization labs. The device is regulated under 21 CFR 870.1255 and requires proper handling, storage, and disposal in accordance with medical device guidelines.

Other devices from Intervalve, Inc.

Questions

AI-generated answers, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary clinical purpose of the V8 Transluminal BAV Catheter, and in which setting is it typically used?

    The V8 Transluminal BAV Catheter is designed to mechanically widen a narrowed aortic valve (aortic stenosis) by inflating a balloon inside the valve during a percutaneous procedure. It is intended for use in cardiac catheterization labs, where interventional cardiologists perform controlled, minimally invasive interventions to improve blood flow through the aortic valve in patients with severe stenosis.

  • Is the V8 Transluminal BAV Catheter intended for single-use or repeated use, and how should it be handled to maintain sterility?

    The device is explicitly supplied as a single-use catheter and comes sterile. To preserve sterility, it must be handled using aseptic techniques—only opened immediately before use, stored in its original packaging until deployment, and disposed of properly after one procedure to prevent contamination or reuse.

  • What regulatory pathway was used to clear this device, and which FDA guidelines govern its use?

    The V8 Transluminal BAV Catheter was cleared through the FDA 510(k) pathway, specifically under Special Clearance (K132728) and classified as a Class 2 device (product code OZT). It is regulated under 21 CFR 870.1255, which mandates adherence to proper handling, storage, and disposal protocols in clinical settings.

  • Are there multiple sizes or models of the V8 Transluminal BAV Catheter, and if so, how are they differentiated?

    The device data lists multiple FEI numbers (Foreign Entity Identification) and registration numbers, which typically correspond to different catheter sizes or configurations (e.g., balloon diameters or shaft lengths). While exact specifications (e.g., nominal diameters) aren’t detailed here, these identifiers imply the manufacturer offers a range of sizes to accommodate varying patient anatomies or procedural needs. For precise sizing, refer to the device’s labeling or manufacturer’s instructions.