Skip to content

The Cdi(R) System 400

by Cardiovascular Devices, Inc.

510(k) K890113

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 9 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 9 Oct 2026. What this means

Regulatory status

as of registry sync 9 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK890113 Date23 May 1989ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 9 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  • Withdrawn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
DJY
Device Class
Class I
Regulation
21 CFR Part 862.2230
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Other devices from Cardiovascular Devices, Inc.

See all devices from Cardiovascular Devices, Inc. →