# K093111: Mikro-Cath, Model 825-0101

- Pathway: 510(k) (Abbreviated)
- Applicant: Millar Instruments, Inc.
- Decided: Jan 5, 2010 after 96 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: 1 generation back to K792177 (1979). 3 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K792177: Millar Mikro-Tip Catheter Transducer, Millar Instruments, Inc. (1979) Summary page 2.
- K952773: Mikro-Tip Angiographic Catheter, Millar Instruments, Inc. (1995) Summary page 2.
- K914479: Microsensor Intracranial Pressure Transducer, Codman & Shurtleff, Inc. (1994) Summary page 2.

## Most influential descendants
- K141275: Endophys Pressure Sensing Sheath Kit (2015), 4 descendants of its own
- 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 Mikro-Cath is a single-use cardiovascular catheter intended to be used for medical research and diagnostic purposes. The catheter is used to measure hemodynamic cardiac pressures in the human body to allow physicians to better understand cardiac health. The catheter would be used as a minimally invasive device under short term limited body contact <24 hours. The typical application will be through the femoral artery with the use of an additional guiding catheter.

Source page: https://510kreport.com/device/K093111
Methodology: https://510kreport.com/methodology