FDA product code PZS: Dual Lumen Ecmo Cannula
PZS is the FDA product code for dual lumen ecmo cannula. It is a Class II device, regulated under 21 CFR 870.4100 and reviewed by the Cardiovascular panel. FDA has cleared 4 510(k) submissions under PZS, 1 in the last five years, from 3 different applicants. The average 510(k) review took 140 days (median 166).
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.
Classification
| Field | Value |
|---|---|
| Device name | Dual Lumen Ecmo Cannula |
| Device class | Class II |
| Regulation | 21 CFR 870.4100 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for PZS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 168 |
| 2018 | 1 | 178 |
| 2021 | 1 | 165 |
| 2023 | 1 | 51 |
Compare with all 510(k) review times · Search every PZS clearance
Top PZS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mc3 Incorporated | 2 | 2018-07-16 |
| Cardiacassist, Inc. | 1 | 2023-10-06 |
| Mc3, Inc. | 1 | 2021-05-03 |
Most recent PZS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232480 | Cardiacassist, Inc. | ProtekDuo Veno-Venous Cannula Sets | 2023-10-06 | 51 |
| K203409 | Mc3, Inc. | MC3 Crescent Jugular Dual Lumen Catheter | 2021-05-03 | 165 |
| K180151 | Mc3 Incorporated | MC3 Jugular Dual Lumen Catheter | 2018-07-16 | 178 |
| K171610 | Mc3 Incorporated | MC3 QuickFlow Dual Lumen Catheter | 2017-11-16 | 168 |
Recalls for PZS devices
openFDA lists no recalls for product code PZS.
Frequently asked questions
What is FDA product code PZS?
PZS is the FDA product code for dual lumen ecmo cannula. It is a Class II device, regulated under 21 CFR 870.4100 and reviewed by the Cardiovascular panel.
What device class is PZS?
Class II, regulation 21 CFR 870.4100. Typical premarket route: 510(k).
How long does a 510(k) take for product code PZS?
Across 4 cleared submissions the average was 140 days from receipt to decision (median 166).
Which companies have the most PZS clearances?
Mc3 Incorporated (2); Cardiacassist, Inc. (1); Mc3, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PZS
- Run a recall and safety report across every PZS manufacturer
- Watch product code PZS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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