510(k) K203409
K203409 is an FDA 510(k) premarket notification submitted by Mc3, Inc. for the device "MC3 Crescent Jugular Dual Lumen Catheter". The FDA issued a decision of Substantially Equivalent on May 3, 2021. The device falls under product code PZS (Dual Lumen Ecmo Cannula), a Class II device regulated under 21 CFR 870.4100. Mc3, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 3, 2021
- Date Received
- November 19, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dual Lumen Ecmo Cannula
- Device Class
- Class II
- Regulation Number
- 870.4100
- Review Panel
- CV
- Submission Type
Long term support greater than 6 hours for acute respiratory or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.