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V8 Transluminal Balloon Aortic Valvuloplasty Catheter

by Intervalve, Inc. 4 variants

510(k) K133607

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 · Traditional NumberK133607 Date11 Feb 2014ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1621-2014 FDA Class II initiated 14 Mar 2014

    Leak issues were discovered through accelerated age testing.

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  • Withdrawn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, 19 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 percutaneous device designed for balloon aortic valvuloplasty, a procedure to dilate a stenotic aortic valve. It falls under the classification of a balloon valvuloplasty catheter, intended to improve blood flow through the aortic valve by mechanically widening narrowed valve leaflets.

This catheter is supplied as a single-use, sterile medical device and is regulated under FDA 510(k) clearance (K133607) with a classification of Class II. It is intended for use in a clinical setting, adhering to standard sterile procedures, and is compatible with MRI safety guidelines as outlined in its regulatory submission. The device is distributed under product code OZT and falls under the regulation number 870.1255.

Other devices from Intervalve, Inc.

Questions

AI-generated answers, 19 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 how does it achieve this goal?

    The V8 Transluminal BAV Catheter is designed specifically for balloon aortic valvuloplasty, a procedure to mechanically widen narrowed (stenotic) aortic valve leaflets. By inflating the balloon within the valve, it improves blood flow through the aortic valve, reducing obstruction and alleviating symptoms caused by aortic stenosis.

  • Is the V8 Transluminal BAV Catheter intended for single-use or repeated use, and what does this mean for clinical workflow?

    The V8 Transluminal BAV Catheter is supplied as a single-use device, meaning it is sterile upon packaging and intended for one-time use in a single patient. This design ensures patient safety by eliminating cross-contamination risks and simplifies clinical workflow, as no reprocessing or sterilization is required between cases.

  • What product codes and regulatory classifications apply to this device, and how does this affect its use in clinical settings?

    The V8 Transluminal BAV Catheter is classified under product code OZT and regulated under FDA regulation number 870.1255, falling under the Class II medical device category. This classification indicates it is subject to FDA 510(k) clearance (K133607) and requires adherence to standard sterile procedures in clinical settings, as it is intended for percutaneous use.

  • Are there any special considerations for storage or handling of the V8 Transluminal BAV Catheter before use?

    While the device data does not specify storage conditions, as a single-use, sterile catheter, it should be stored in its original packaging to maintain sterility until use. Clinicians should follow manufacturer guidelines (available in the accompanying documentation) to ensure proper handling, including protection from contamination and environmental damage before deployment.