DXZ · Class II · 21 CFR 870.3470

FDA Product Code DXZ: Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Leading manufacturers include Boston Scientific Corp, Aesculap, Inc. and Vascutek, Ltd..

90
Total
90
Cleared
137d
Avg days
1977
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 393d recently vs 134d historically

FDA 510(k) Cleared Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene Devices (Product Code DXZ)

90 devices
1–24 of 90
Cleared Apr 18, 2025
PeriBeam® Pericardial Membrane
K240775
Tamabio
Cardiovascular · 393d
Cleared Jul 08, 2020
Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch
K200955
Vascutek, Ltd.
Cardiovascular · 90d
Cleared Oct 27, 2015
PremiPatch PTFE Pledget
K151865
Aesculap, Inc.
Cardiovascular · 111d
Cleared Jul 22, 2004
PTFE FELTS AND PLEDGETS
K041716
Boston Scientific Corp
Cardiovascular · 28d

About Product Code DXZ - Regulatory Context

510(k) Submission Activity

90 total 510(k) submissions under product code DXZ since 1977, with 90 receiving FDA clearance (average review time: 137 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - DXZ Product Code

Recent submissions under DXZ have taken an average of 393 days to reach a decision - up from 134 days historically. Manufacturers should account for longer review timelines in current project planning.

DXZ devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →