510(k) K203409
- Device
- MC3 Crescent Jugular Dual Lumen Catheter
- Applicant
- Mc3, Inc.
- 510(k) number
- K203409
- Product code
- PZS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-05-03
- Date received
- 2020-11-19
- Regulation
- 870.4100
- Classification name
- Dual Lumen Ecmo Cannula
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Martha Rumford
- Address
- 2555 Bishop Cir. W Dexter MI US 48130 48130
FDA Registration Numbers#
- 3011468686
- 9611665
- 9680841
- 1718850