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Pall SQ40S Blood Filter (SQ40S/SQ40ST)

by Pall Biomedical Products Co.

510(k) K960993

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 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK960993 Date22 Apr 1996ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1157-2026 FDA Class II initiated 3 Nov 2025

    Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.

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  • Withdrawn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
CAK
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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