PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM— 510(k) K120953

Name: FDA 510(k) clearance K120953
Creator: U.S. Food and Drug Administration
Published: 2012-12-10

Substantially Equivalent

Tlelflex Medical, Inc.

FDA 510(k) clearance K120953 for PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM, Substantially Equivalent on 2012-12-10. Applicant: Tlelflex Medical, Inc.. Device class: 2.

Clearance details

Applicant: Tlelflex Medical, Inc.
Product code: Code CAC
Device class: Class 2
Regulation: 21 CFR 868.5830
Advisory panel: Anesthesiology
Date received: 2012-03-30
Decision date: 2012-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CAC

product code CAC

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.