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Cordia N

by Cordis Corp.

510(k) K800991

Cordia N is a Class II device made by Cordis Corp., cleared under FDA 510(k) K800991 on 8 May 1980, active as of 12 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 12 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 12 Oct 2026.

Regulatory status

as of registry sync 12 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK800991 Date8 May 1980ClearedStatusActive

Official records

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  • Withdrawn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
DHC
Device class
Class II
Regulation
21 CFR Part 866.5820
Advisory committee
Immunology
FDA decision
SESE Substantially Equivalent

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Other devices filed under FDA product code DHC (System, Test, Systemic Lupus Erythematosus).

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