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Hemostasis Valve

by Applied Vascular Devices, Inc.

510(k) K895214

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 · Traditional NumberK895214 Date14 Nov 1989ClearedStatusActive

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  • Withdrawn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)

510(k) Number
FDA Product Code
DYB
Device Class
Class II
Regulation
21 CFR Part 870.1340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Hemostasis Valve is a medical device designed to control blood flow during vascular procedures. It functions to maintain hemostasis while allowing for the passage of instruments into the vasculature.

This device is manufactured by Applied Vascular Devices, Inc. and was cleared by the FDA through the 510(k) pathway under K895214.

Other devices from Applied Vascular Devices, Inc.

See all devices from Applied Vascular Devices, Inc. →

Questions

AI-generated answers, 21 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 function of the Hemostasis Valve?

    The Hemostasis Valve is designed to control blood flow during vascular procedures. It functions to maintain hemostasis while simultaneously allowing for the passage of medical instruments into the vasculature.

  • What is the regulatory status of this device?

    This device was cleared by the FDA through the 510(k) pathway under K895214. The decision description for this submission is Substantially Equivalent.

  • Who is the manufacturer of the Hemostasis Valve?

    The Hemostasis Valve is manufactured by Applied Vascular Devices, Inc., located in Laguna Hills, California.