510(k) K223168
K223168 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance Biosurface". The FDA issued a decision of Substantially Equivalent on Apr 19, 2023. The device falls under product code QWF (Tubing, Long Term Support Greater Than 6 Hours), a Class II device regulated under 21 CFR 870.4100. Medtronic, Inc. has 247 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 19, 2023
- Date Received
- Oct 11, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubing, Long Term Support Greater Than 6 Hours
- Device Class
- Class II
- Regulation Number
- 870.4100
- Review Panel
- CV
- Submission Type
- 510(k)
The tubing and accessories are intended to connect perfusion devices and circulate blood as part of extracorporeal membrane oxygenation lasting longer than 6 hours.