# K190098: Endophys Pressure Sensing Sheath

- Pathway: 510(k) (Special)
- Applicant: Endophys Holdings, LLC
- Decided: Mar 7, 2019 after 44 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- 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). 30 ancestors in all.
No later device cites it as a predicate yet.
1 of 31 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173399: Endophys Pressure Sensing Sheath Kit- 8F, Endophys Holdings, LLC (2017) Summary page 4.

## Indications for use
The Endophys Pressure Sensing Sheath Kit (Endophys Pressure Sensing Sheath and vessel dilator) is intended to facilitate the introduction of diagnostic and interventional devices into the vasculature and to continuously measure blood pressure during the procedure when used with the Endophys Blood Pressure Monitor. Together, the Pressure Sensing Sheath and the Blood Pressure Monitor comprise the Endophys Pressure Sensing Access System (PSAS™).

Source page: https://510kreport.com/device/K190098
Methodology: https://510kreport.com/methodology