# K151610: Comet Pressure Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Oct 6, 2015 after 113 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: 9 generations back to K003122 (2001). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 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 5.

## Most influential descendants
- K193279: Comet II Pressure Guidewire (2019), 0 descendants of its own

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

Source page: https://510kreport.com/device/K151610
Methodology: https://510kreport.com/methodology