Dual Lumen Ecmo Cannula
The Dual Lumen ECMO Cannula is a cardiovascular device used to provide long-term extracorporeal membrane oxygenation (ECMO) support for more than six hours in patients with acute respiratory or acute cardiopulmonary failure when other available treatments have failed and continued clinical deterioration is expected or death is imminent. It is classified as a Class 2 device under regulation 870.4100, requiring 510(k) premarket notification, and falls within the Cardiovascular (CV) medical specialty. The product code is PZS. It is not an implant, and while life-sustaining in practice, the flag is not set in the database record.
Basic Information
- Product Code
- PZS
- Device Class
- FDA class 2
- Regulation Number
- 870.4100
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K232480 | ProtekDuo Veno-Venous Cannula Sets | Oct 06, 2023 | Substantially Equivalent | Cardiacassist, Inc. |
| K203409 | MC3 Crescent Jugular Dual Lumen Catheter | May 03, 2021 | Substantially Equivalent | Mc3, Inc. |
| K180151 | MC3 Jugular Dual Lumen Catheter | Jul 16, 2018 | Substantially Equivalent | Mc3 Incorporated |
| K171610 | MC3 QuickFlow Dual Lumen Catheter | Nov 16, 2017 | Substantially Equivalent | Mc3 Incorporated |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.