# K952773: Mikro-Tip Angiographic Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Millar Instruments, Inc.
- Decided: Nov 7, 1995 after 144 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K093111: Mikro-Cath, Model 825-0101 (2010), 6 descendants of its own
- 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

## Recalls of this device
- Mar 8, 2011 · Not classified · Z-1725-2011: Possibility of epoxy debris particles inside the catheter lumen.
- Oct 14, 2010 · Not classified · Z-0401-2011: The sterile packaging was found to be compromised when tested after shipping conditions. This may result in infection or transmission of disease. A test for transportation of sterile package was condu

Source page: https://510kreport.com/device/K952773
Methodology: https://510kreport.com/methodology