PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM— 510(k) K140205

Clearance details

Applicant

Teleflexmedical, Inc.

Product code

Code CAC

Device class

Class 2

Regulation

21 CFR 868.5830

Advisory panel

Anesthesiology

Date received

2014-01-27

Decision date

2014-10-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Research Triangle Park, NC, US

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Death

11

Malfunction

477

Total

488

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1582-2016 — Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08LF, Rx Only, Teleflex Medical. Product Usage: Pleur-Evacs are sterile, single-use, chest drainage systems intended for post-operative useClass II·Terminated·Teleflex Medical·20160330

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140205.