# K153742: Apollo Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Brosmed Medical Co., Ltd.
- Decided: Aug 8, 2016 after 224 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: 2 generations back to P790017 (1980). 5 ancestors in all.
1 later device descends from it; 1 cites 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)
- K133852: Apollo Balloon Dilatation Catheter, Brosmed Medical (2014) Summary page 4.
- P790017: Usci Dilatation Catheter, Medtronic, Ireland (1980) Summary page 4.
- P810046: Simpson-Robert Coronary Balloon Dilatation Cathete, Advanced Cardiovascular Systems, Inc. (1982) Summary page 4.
- P860019: Scimed Ptca Dilatation Catheter, Scimed Life Systems, Inc. (1986) Summary page 4.
- P880003: Cordis Ptca Dilatation Catheter, Cordis Corp. (1988) Summary page 4.

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

## Indications for use
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 • balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction • balloon dilatation of a stent after implantation (balloon models 2.00 mm – 5.00 mm only)

Source page: https://510kreport.com/device/K153742
Methodology: https://510kreport.com/methodology