# K113584: Pressurewire Certus, Certus 300, Aeris, Aeris 300, and Receiver

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: Mar 2, 2012 after 88 days
- Product code: DXO (Transducer, Pressure, Catheter Tip)
- Device class: 2
- Regulation: 21 CFR 870.2870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K003122 (2001). 17 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080813: Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), Receiver, Radi Medical Systems AB (2008) Summary page 1.

## Most influential descendants
- K131452: Pressurewire; Certus, Certus 300, Aeris, Aeris 300 (2013), 7 descendants of its own
- K140466: Pressurewire: Aeris Agile Tip, Aeris Agile Tip 300, Certus Agile Tip, Certus Agile Tip 300 (2014), 2 descendants of its own
- K161171: PressureWire X Guidewire (2016), 1 descendant of its own
- K151610: Comet Pressure Guidewire (2015), 1 descendant of its own
- K193279: Comet II Pressure Guidewire (2019), 0 descendants of its own

## Indications for use
PressureWire TM 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/K113584
Methodology: https://510kreport.com/methodology