FDA Product Code PZS: Dual Lumen Ecmo Cannula
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.
Leading manufacturers include Mc3 Incorporated, Mc3, Inc. and Cardiacassist, Inc..
4
Total
4
Cleared
141d
Avg days
2017
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Dual Lumen Ecmo Cannula Devices (Product Code PZS)
4 devices
Cleared
Oct 06, 2023
ProtekDuo Veno-Venous Cannula Sets
Cardiacassist, Inc.
Cardiovascular
51d
Cleared
May 03, 2021
MC3 Crescent Jugular Dual Lumen Catheter
Mc3, Inc.
Cardiovascular
165d
Cleared
Jul 16, 2018
MC3 Jugular Dual Lumen Catheter
Mc3 Incorporated
Cardiovascular
178d
About Product Code PZS - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code PZS since 2017, with 4 receiving FDA clearance (average review time: 141 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.