510(k) K251831
K251831 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "Bio-Medicus Life Support Catheter and Introducer". The FDA issued a decision of Substantially Equivalent on January 15, 2026. The device falls under product code QHW (Single Lumen Ecmo Cannula), a Class II device regulated under 21 CFR 870.4100. Medtronic, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 15, 2026
- Date Received
- June 13, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Single Lumen Ecmo Cannula
- Device Class
- Class II
- Regulation Number
- 870.4100
- Review Panel
- CV
- Submission Type
Single-lumen cannulas/catheters to be used with an extracorporeal circuit intended for use in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.