510(k) K251831
- Device
- Bio-Medicus Life Support Catheter and Introducer
- Applicant
- Medtronic, Inc.
- 510(k) number
- K251831
- Product code
- QHW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-01-15
- Date received
- 2025-06-13
- Regulation
- 870.4100
- Classification name
- Single Lumen Ecmo Cannula
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Elizabeth Rose
- Address
- 7611 Northland Dr. Minneapolis MN US 55428 55428
FDA Registration Numbers#
- 2011171
- 9617601
- 2184009
- 1928237
- 3011468686