Thoratec CentriMag Return (Arterial) Cannula Kit— 510(k) K152161

Name: FDA 510(k) clearance K152161
Creator: U.S. Food and Drug Administration
Published: 2015-09-18

Substantially Equivalent

Thoratec Corporation

FDA 510(k) clearance K152161 for Thoratec CentriMag Return (Arterial) Cannula Kit, Substantially Equivalent on 2015-09-18. Applicant: Thoratec Corporation. Device class: 2.

Clearance details

Applicant: Thoratec Corporation
Product code: Code DWF
Device class: Class 2
Regulation: 21 CFR 870.4210
Advisory panel: Cardiovascular
Date received: 2015-08-03
Decision date: 2015-09-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Pleasanton, CA, US

Download summary PDF View on FDA.gov ↗

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K152190 — Thoratec CentriMag Drainage (Venous) Cannula Kit2015-09-18

Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

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.