K240534
- 510(k) number
- K240534
- Device name
- Bio-Medicus Life Support Catheter and Introducer
- Applicant
- Medtronic, Inc. MN · US
- Product code
- QHW — Single Lumen Ecmo Cannula
- Decision date
- 2024-04-19
- Date received
- 2024-02-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K240534.pdf
Official FDA record: K240534
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.