# K041716: Ptfe Felts and Pledgets

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Jul 22, 2004 after 28 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.
13 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) PTFE Felts and Pledgets (Preamendment devices): named in the summary without a submission number

## Most influential descendants
- K063349: Cormatrix Patch for Cardiac Tissue Repair (2007), 11 descendants of its own
- K140306: Cormatrix Protect Ecm Envelope (2014), 4 descendants of its own
- K173242: CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large) (2017), 3 descendants of its own
- K182255: CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large) (2018), 2 descendants of its own
- K152127: CorMatrix Tyke (2016), 2 descendants of its own

## Indications for use
Felts: Indicated for Ventricular aneurysmectomy; tissue prosthesis, and suture buttressing. Pledgets: Indicated for Tissue, prosthesis, and suture buttressing.

Source page: https://510kreport.com/device/K041716
Methodology: https://510kreport.com/methodology