# K141275: Endophys Pressure Sensing Sheath Kit

- Pathway: 510(k) (Traditional)
- Applicant: Endophys, Inc.
- Decided: Jan 7, 2015 after 236 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: 7 generations back to K003122 (2001). 27 ancestors in all.
4 later devices descend from it; 1 cites it directly.
1 of 32 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052557: Super Sheath Introducer Sheath, Togo Medikit Co., Ltd. (2006) Summary page 4.
- K120212: Afx Introducer System, Endologix, Inc. (2012) Summary page 4.
- K093111: Mikro-Cath, Model 825-0101, Millar Instruments, Inc. (2010) Summary page 4.
- K132474: Cardiovascular Pressure Measurement (CPM) System, Navvus Catheter, Acist Medical Systems (2014) Summary page 4.

## Most influential descendants
- K160272: Endophys Pressure Sensing Sheath Kit (2016), 3 descendants of its own
- K173399: Endophys Pressure Sensing Sheath Kit- 8F (2017), 1 descendant of its own
- K190098: Endophys Pressure Sensing Sheath (2019), 0 descendants of its own
- K180620: Endophys Pressure Sensing Sheath Kit (2018), 0 descendants of its own

## Indications for use
The Endophys Pressure Sensing Sheath Kit (Endophys Pressure Sensing Sheath, vessel dilator and guidewire) 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.

Source page: https://510kreport.com/device/K141275
Methodology: https://510kreport.com/methodology