# K133587: Pressurewire Aeris Agile Tip; Pressurewire Aeris Agile Tip 300

- Pathway: 510(k) (Special)
- Applicant: St. Jude Medical Systems AB
- Decided: Dec 20, 2013 after 29 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K003122 (2001). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131452: Pressurewire; Certus, Certus 300, Aeris, Aeris 300, St. Jude Medical Systems AB (2013) Summary page 1.

## Indications for use
PressureWireM is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessels.

Source page: https://510kreport.com/device/K133587
Methodology: https://510kreport.com/methodology