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Rotating Hemostatic Valve

by Devices For Vascular Intervention, Inc. 510(k)

Active United States

510(k) K883916

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK883916 Date28 Oct 1988ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DQY
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Rotating Hemostatic Valve is a device designed to maintain hemostasis during catheter-based procedures by allowing for the passage of instruments while minimizing blood loss. It is used in vascular interventions, particularly in procedures involving venous stents.

The Rotating Hemostatic Valve is supplied with FDA 510K authorizations and is classified under product code DQY. It is substantially equivalent and has a clearance type of Traditional. The device is used in the cardiovascular medical specialty and has been reviewed by the Cardiovascular advisory committee.

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Questions

AI-generated answers, 25 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 Rotating Hemostatic Valve used for?

    The Rotating Hemostatic Valve is used to maintain hemostasis during catheter-based procedures, particularly in vascular interventions involving venous stents, by allowing instrument passage while minimizing blood loss.

  • Is the Rotating Hemostatic Valve supplied sterile?

    The device data does not specify if the Rotating Hemostatic Valve is supplied sterile, so it's recommended to check the packaging or manufacturer's instructions for this information.

  • What is the regulatory status of the Rotating Hemostatic Valve?

    The Rotating Hemostatic Valve has FDA 510K authorizations, indicating it has been cleared for use in the United States.