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Viaspan (Belzer Uw - Css)

by The Dupont Merck Pharmaceutical Co.

510(k) K944866

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK944866 Date22 Apr 1996ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1437-2012 FDA Not yet classified initiated 30 Mar 2012

    Lack of assurance of sterility

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  • Withdrawn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
KDL
Device Class
Class II
Regulation
21 CFR Part 876.5880
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent