510(k) K223168
- Device
- Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with BalanceĀ Biosurface
- Applicant
- Medtronic, Inc.
- 510(k) number
- K223168
- Product code
- QWF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-04-19
- Date received
- 2022-10-11
- Regulation
- 870.4100
- Classification name
- Tubing, Long Term Support Greater Than 6 Hours
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Anna Wetherille
- Address
- 8200 Coral Sea St. N.E Mounds View MN US 55112 55112
FDA Registration Numbers
- 3002845651
- 9611665
- 3030191221
- 9617601
- 3011468686
- 3012172416