# K953289: Tetrafluoroethylene (Tfe) Polymer Pledget

- Pathway: 510(k) (Traditional)
- Applicant: Davis & Geck, Inc.
- Decided: Aug 21, 1995 after 38 days
- Product code: DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 870.3470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K141060: Chord-X Pre-Measured Loops for Mitral Chordal Replacement (2014), 1 descendant of its own
- K252126: MitraPatch Mitral Valve Repair System (2025), 0 descendants of its own

Source page: https://510kreport.com/device/K953289
Methodology: https://510kreport.com/methodology