# DXZ: Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

- Device class: 2; regulation: 21 CFR 870.3470; FDA's rule: 510(k) required
- FDA decisions: 90
- 510(k) review time 2021–2025: median 393 days (middle half 393–393)
- Recalls: 14 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2010: 3
- 2011: 2
- 2012: 1
- 2013: 1
- 2014: 3
- 2015: 2
- 2016: 2
- 2017: 1
- 2020: 1
- 2025: 1

## Most-cited predicates
- K983602: CV Peri-Guard and Vascu-Guard (1998), cited by 10
- K921895: Tissue Patch, Tissue Graft (1992), cited by 7
- K942010: Vascu-Guard (1994), cited by 6
- K051405: Regensis Pericardial Patch (2005), cited by 5
- K063349: Cormatrix Patch for Cardiac Tissue Repair (2007), cited by 5
- K040415: Peri-Strips Staple Line Reinforcement - Sleeve and Strip Configurations - and Peri-Strips Dry Staple Line Reinforcement (2004), cited by 4
- K971726: CV Peri-Guard - Cardiovascular Patch (1998), cited by 4
- K963611: Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft Patch,Vascutek Thin Wall Carotid Patch (1996), cited by 4
- K842066: Peri-Guard Pericardial Patch (1985), cited by 4
- K830806: Vascular Graft/Bifurcated/Fep-Ringed (1983), cited by 3

Source page: https://510kreport.com/product-code/DXZ
Data by year (CSV): https://510kreport.com/product-code/DXZ.csv