# K110133: Empira RX Ptca Dilatation Catheter, Empria NC RX Ptca Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Creganna-Tactx Medical
- Decided: Jun 10, 2011 after 143 days
- Product code: LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.5100
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P860019 (1986). 2 ancestors in all.
10 later devices descend from it; 5 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P880003: Cordis Ptca Dilatation Catheter, Cordis Corp. (1988) Summary page 1.
- P860019: Scimed Ptca Dilatation Catheter, Scimed Life Systems, Inc. (1986) Summary page 1.

## Most influential descendants
- K111544: Glider Ptca Balloon Catheter (2012), 6 descendants of its own
- K121681: Glider Ptca Balloon Catheter (2012), 4 descendants of its own
- K133633: Chocolate Ptca Bolloon Catheter (2014), 3 descendants of its own
- K150292: Chocolate PTCA Balloon Catheter (2015), 2 descendants of its own
- K160961: Mozec NC-Rx PTCA Baloon Dilatation Catheter (2016), 1 descendant of its own

## Recalls of this device
- Jun 23, 2014 · Class II · Z-2556-2014: The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove
- Jun 23, 2014 · Class II · Z-2557-2014: The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove
- Feb 5, 2013 · Class II · Z-1784-2014: Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.

## Indications for use
The EMPIRA Rx PTCA Catheter and EMPIRA NC Rx PTCA Dilatation Catheter are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The EMPIRA NC Rx PTCA Dilatation Catheter is also indicated for post-delivery expansion of balloon expandable stents.

Source page: https://510kreport.com/device/K110133
Methodology: https://510kreport.com/methodology