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Pleur-Evac Sahara Plus Continuous Reinfusion and Autotransfusion System

by Teleflexmedical, Inc.

510(k) K140205

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK140205 Date23 Oct 2014ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1582-2016 FDA Class II initiated 30 Mar 2016

    The label on the Tyvek bag is missing. This is used by customers to identify material code, lot number, and expiration date once the product is removed from the shipper box.

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  • Withdrawn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
CAC
Device Class
Class II
Regulation
21 CFR Part 868.5830
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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