# P810046: Simpson-Robert Coronary Balloon Dilatation Cathete

- Pathway: PMA
- Applicant: Advanced Cardiovascular Systems, Inc.
- Decided: Mar 3, 1982 after 173 days
- Product code: LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.5100
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
18 later devices descend from it; 5 cite it directly.
0 of 19 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
- K103808: Sapphire NC (2011), 11 descendants of its own
- K162209: Sapphire NC Plus (2016), 9 descendants of its own
- K103657: Sapphire (2011), 5 descendants of its own
- K163114: Sapphire II PRO (2017), 4 descendants of its own
- K192344: Sapphire NC Plus Coronary Dilatation Catheter (2019), 3 descendants of its own

## Recalls of this device
- Jun 17, 2009 · Not classified · Z-1804-2009: Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures.
- Jun 17, 2009 · Not classified · Z-1805-2009: Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures.
- Jun 17, 2009 · Not classified · Z-1806-2009: Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures.
- Jun 17, 2009 · Not classified · Z-1807-2009: Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures.

Source page: https://510kreport.com/device/P810046
Methodology: https://510kreport.com/methodology