DXZClass II
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
21 CFR 870.3470 / Cardiovascular
DXZ is the FDA product code for Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene, a class II device type, regulated under 21 CFR 870.3470. As of , FDA records hold 90 510(k) clearances under this code, the most recent dated , and 20 recalls.
Classification record
- Product code
- DXZ
- Device name
- Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- Regulation
- 21 CFR 870.3470
- Device class
- Class II
- Review panel
- Cardiovascular
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 90
- Ingested recalls
- 20
Clearances, product code DXZ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 2 |
| 1979 | 1 |
| 1980 | 1 |
| 1981 | 3 |
| 1982 | 1 |
| 1983 | 5 |
| 1984 | 3 |
| 1985 | 1 |
| 1988 | 1 |
| 1991 | 6 |
| 1992 | 2 |
| 1993 | 2 |
| 1994 | 2 |
| 1995 | 3 |
| 1996 | 3 |
| 1997 | 4 |
| 1998 | 5 |
| 1999 | 3 |
| 2000 | 4 |
| 2001 | 4 |
| 2002 | 4 |
| 2003 | 2 |
| 2004 | 3 |
| 2005 | 3 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 2 |
| 2009 | 1 |
| 2010 | 3 |
| 2011 | 2 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 3 |
| 2015 | 2 |
| 2016 | 2 |
| 2017 | 1 |
| 2020 | 1 |
| 2025 | 1 |
Applicants with the most clearances
Product code DXZ| Applicant | 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 |
| Artivion, Inc. | 3 |
| Ethicon, Inc | 3 |
| Shelhigh, Inc. | 3 |
| Somanetics Corp. | 3 |
| Atrium Medical Corporation | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.