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Celsior Cold Flush, Storage and Transport Solution for Hearts

by Sangstat Medical Corp.

510(k) K991594

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK991594 Date5 Aug 1999ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2220-2025 FDA Class II initiated 13 Mar 2025

    The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing.

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  • Withdrawn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

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