Cannula for Organ Perfusion— 510(k) K203262

Name: FDA 510(k) clearance K203262
Creator: U.S. Food and Drug Administration
Published: 2021-07-01

Substantially Equivalent

Bridge TO Life, Ltd.

FDA 510(k) clearance K203262 for Cannula for Organ Perfusion, Substantially Equivalent on 2021-07-01. Applicant: Bridge TO Life, Ltd.. Device class: 2.

Clearance details

Applicant: Bridge TO Life, Ltd.
Product code: Code KDN
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 2020-11-05
Decision date: 2021-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, SC, US

Download summary PDF View on FDA.gov ↗

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