# K052416: Peripro Patch

- Pathway: 510(k) (Traditional)
- Applicant: Hancock/Jaffe Laboratories
- Decided: Oct 25, 2005 after 53 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The PeriProTM Patch is indicated for cardiac and vascular reconstruction and repair. This may include intra-cardiac patching and peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda and tibial arteries and arteriovenous access revisions. PeriProTM will be restricted to sale by or on the order of physician (or properly licensed practitioner).

Source page: https://510kreport.com/device/K052416
Methodology: https://510kreport.com/methodology