510(k) K261335
K261335 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "VitalFlow Set with Balance Biosurface". The FDA issued a decision of Substantially Equivalent on Jul 31, 2026. The device falls under product code QJZ (Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure), a Class II device regulated under 21 CFR 870.4100. Medtronic, Inc. has 249 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 31, 2026
- Date Received
- Apr 23, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
- Device Class
- Class II
- Regulation Number
- 870.4100
- Review Panel
- CV
- Submission Type
- 510(k)
Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.