# K193279: Comet II Pressure Guidewire

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Dec 23, 2019 after 26 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: 10 generations back to K003122 (2001). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151610: Comet Pressure Guidewire, Boston Scientific Corporation (2015) Summary page 4.

## Indications for use
The Comet II Pressure Guidewire is indicated to direct a catheter through a blood vessel and measure physiological parameters in the coronary and peripheral blood vessels.

Source page: https://510kreport.com/device/K193279
Methodology: https://510kreport.com/methodology