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Capiox Hardshell Venous Reservoir

by Terumo Medical Corp.

510(k) K894664

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 NumberK894664 Date20 Apr 1990ClearedStatusActive

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  • Withdrawn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
DTN
Device class
Class II
Regulation
21 CFR Part 870.4400
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Capiox Hardshell Venous Reservoir is a cardiopulmonary bypass blood reservoir. It is designed to collect and store blood during extracorporeal circulation procedures.

This device is regulated as a Class II medical device under product code DTN and regulation number 870.4400. It received FDA 510(k) clearance under K894664.

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