FDA product code DXZ: Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
DXZ is the FDA product code for patch, pledget and intracardiac, petp, ptfe, polypropylene. It is a Class II device, regulated under 21 CFR 870.3470 and reviewed by the Cardiovascular panel. FDA has cleared 90 510(k) submissions under DXZ, 1 in the last five years, from 41 different applicants. The average 510(k) review took 137 days (median 90); 393 days on average over the last three years. FDA has posted 20 recalls for DXZ devices, 5 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Device class | Class II |
| Regulation | 21 CFR 870.3470 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for DXZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 182 |
| 2020 | 1 | 90 |
| 2025 | 1 | 393 |
Compare with all 510(k) review times · Search every DXZ clearance
Top DXZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| W. L. Gore & Associates, Inc. | 13 | 2001-09-20 |
| Chase Medical, Inc. | 7 | 2002-09-20 |
| Cormatrix Cardiovascular, Inc. | 5 | 2016-02-04 |
| Meadox Medicals, Div. Boston Scientific Corp. | 5 | 1996-09-10 |
| Bio-Vascular, Inc. | 4 | 1998-11-12 |
36 more applicants have DXZ clearances. See the full list in Caduvo.
Most recent DXZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240775 | Tamabio | PeriBeam® Pericardial Membrane | 2025-04-18 | 393 |
| K200955 | Vascutek, Ltd. | Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch | 2020-07-08 | 90 |
| K162506 | Cryolife, Inc. | PhotoFix Decellularized Bovine Pericardium | 2017-03-09 | 182 |
| K162579 | Admedus Regen Pty, Ltd. | VascuCel | 2016-10-14 | 29 |
| K152127 | Cormatrix Cardiovascular, Inc. | CorMatrix Tyke | 2016-02-04 | 188 |
Recalls for DXZ devices
20 product recalls in 17 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2025-10-09.
| Year | Recalls |
|---|---|
| 2018 | 3 |
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code DXZ?
DXZ is the FDA product code for patch, pledget and intracardiac, petp, ptfe, polypropylene. It is a Class II device, regulated under 21 CFR 870.3470 and reviewed by the Cardiovascular panel.
What device class is DXZ?
Class II, regulation 21 CFR 870.3470. Typical premarket route: 510(k).
How long does a 510(k) take for product code DXZ?
Across 90 cleared submissions the average was 137 days from receipt to decision (median 90).
Which companies have the most DXZ clearances?
W. L. Gore & Associates, Inc. (13); Chase Medical, Inc. (7); Cormatrix Cardiovascular, Inc. (5); Meadox Medicals, Div. Boston Scientific Corp. (5); Bio-Vascular, Inc. (4).
Have DXZ devices been recalled?
Yes: 20 product recalls across 17 recall events; the most recent began 2025-10-09.
Next steps
- Run an FDA pathway report with predicate devices for product code DXZ
- Run a recall and safety report across every DXZ manufacturer
- Watch product code DXZ 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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