# K130943: Aigis RX R PM/ Aigis RX R Icd

- Pathway: 510(k) (Traditional)
- Applicant: Tyrx, Inc.
- Decided: May 20, 2013 after 46 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K931386 (1993). 19 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063091: Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601, Tyrx Pharma, Inc. (2008) Summary page 1.

## Most influential descendants
- K142611: TYRX Neuro Absorbable Antibacterial Envelope (2014), 4 descendants of its own
- K140306: Cormatrix Protect Ecm Envelope (2014), 4 descendants of its own
- K180030: TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) (2018), 3 descendants of its own
- K173242: CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large) (2017), 3 descendants of its own
- K150291: TYRX Neuro Absorbable Antibacterial Envelope (2015), 3 descendants of its own

## Indications for use
AIGISRx® R is intended to hold a pacemaker pulse generator or defibrillator securely in order to create a stable environment when implanted in the body. AIGISRx® R contains the antimicrobial agents rifampin and minocycline which have been shown to reduce infection in in vivo models of bacterial challenge following surgical implantation of the generator or defibrillator. This device is only intended to be used in conjunction with pacemakers and implantable defibrillators. AIGISRx® R is intended for single patient, one-time use only.

Source page: https://510kreport.com/device/K130943
Methodology: https://510kreport.com/methodology