510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PZSClass II

Dual Lumen Ecmo Cannula

21 CFR 870.4100 / Cardiovascular
FDA source (opens on fda.gov)

PZS is the FDA product code for Dual Lumen Ecmo Cannula, a class II device type, regulated under 21 CFR 870.4100. FDA's definition for this code reads: "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". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PZS
Device name
Dual Lumen Ecmo Cannula
FDA 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.
Regulation
21 CFR 870.4100
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code PZS

By decision year
4 clearances under product code PZS with a decision year between 2017 and 2023, 2017 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PZS by decision year
YearClearances
20171
20181
20211
20231

Applicants with the most clearances

Product code PZS
Applicants holding the most 510(k) clearances under product code PZS
ApplicantClearances
Mc3 Incorporated2
Cardiacassist, Inc.1
MC3, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code