Bio-Medicus Life Support Catheter and Introducer— 510(k) K201057

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K201057 for Bio-Medicus Life Support Catheter and Introducer, Substantially Equivalent on 2022-01-14. Applicant: Medtronic, Inc..

Clearance details

Applicant: Medtronic, Inc.
Product code: Code QHW
Advisory panel: Cardiovascular
Date received: 2020-04-21
Decision date: 2022-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mounds View, MN, US

Download summary PDF View on FDA.gov ↗

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