# K133852: Apollo Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Brosmed Medical
- Decided: Sep 19, 2014 after 274 days
- Product code: LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.5100
- 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 P790017 (1980). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P790017: Usci Dilatation Catheter, Medtronic, Ireland (1980) Summary page 5.
- P810046: Simpson-Robert Coronary Balloon Dilatation Cathete, Advanced Cardiovascular Systems, Inc. (1982) Summary page 5.
- P860019: Scimed Ptca Dilatation Catheter, Scimed Life Systems, Inc. (1986) Summary page 5.
- P880003: Cordis Ptca Dilatation Catheter, Cordis Corp. (1988) Summary page 5.

## Most influential descendants
- K153742: Apollo Balloon Dilatation Catheter (2016), 1 descendant of its own
- K230705: POT PTCA Balloon Dilatation Catheter (2023), 0 descendants of its own

## Indications for use
The Apollo Balloon Dilatation Catheter is indicated for: 1. The balloon dilatation catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion 2. Balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction 3. Balloon dilatation of a stent after implantation (balloon models 2.00 mm – 5.00 mm only) Note: Bench testing was conducted with the Apollo Balloon Dilatation Catheter and marketed balloon expandable stents. Consideration should be taken when this device is used with different manufacturers’ stents due to difference in stent design.

Source page: https://510kreport.com/device/K133852
Methodology: https://510kreport.com/methodology