DXZ

Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Product code
DXZ
Device name
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Device class
Class 2
21 CFR
21 CFR 870.3470
Medical specialty
Cardiovascular
Marketing pathway
510(K)
Flag
Implant
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
90 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-04-18.

NumberDecision dateApplicantDevice nameSummary
K2407752025-04-18TamabioPeriBeam® Pericardial MembranePDF

1 summaries are archived here for direct download.

Official FDA classification page: DXZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).