# P860019: Scimed Ptca Dilatation Catheter

- Pathway: PMA
- Applicant: Scimed Life Systems, Inc.
- Decided: Nov 28, 1986 after 189 days
- Product code: LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.5100
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
69 later devices descend from it; 21 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Most influential descendants
- K113220: Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca  Dilatation Catheter (Over-the-Wire) (2012), 15 descendants of its own
- K103808: Sapphire NC (2011), 11 descendants of its own
- K110133: Empira RX Ptca Dilatation Catheter, Empria NC RX Ptca Dilatation Catheter (2011), 10 descendants of its own
- K162209: Sapphire NC Plus (2016), 9 descendants of its own
- K121196: Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter (Over-the-Wire) (2012), 8 descendants of its own

## Recalls of this device
- May 1, 2007 · Not classified · Z-2165-2008: The units within this lot may not meet thickness specifications surrounding the wire exit port wall, which may result in an air embolization if the Port Septum Wall burts.
- Nov 1, 2005 · Not classified · Z-2166-2008: Two lots may not be correctly labeled. Specifically , a 2.5 mm x 12 mm unit was incorrectly labeled as a 3.5 x 20 mm unit on the box and tyvek label.
- Aug 20, 2003 · Not classified · Z-0030-04: Some of the recalled catheters have a component that has levels of pyrogens above specification.
- Aug 20, 2003 · Not classified · Z-0031-04: Some of the recalled catheters have a component that has levels of pyrogens above specification.
- Aug 20, 2003 · Not classified · Z-0032-04: Some of the recalled catheters have a component that has levels of pyrogens above specification.

Source page: https://510kreport.com/device/P860019
Methodology: https://510kreport.com/methodology