# K162625: SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters

- Pathway: 510(k) (Traditional)
- Applicant: B. Braun Interventional Systems, Inc.
- Decided: Jun 12, 2017 after 265 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: 4 generations back to P860019 (1986). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113220: Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca  Dilatation Catheter (Over-the-Wire), Boston Scientific Corporation (2012) Summary page 4.
- K121196: Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter (Over-the-Wire), Boston Scientific Corp (2012) Summary page 4.
- K130391: Emerge Monorail Ptca Dilatation Catheter, Emerge Push Monorail Ptca Dilatation Catheter, Emerge Over-the-Wire Ptca Dilat, Boston Scientific Corp (2013) Summary page 4.

## Indications for use
The SeQuent® Neo PTCA Dilatation Catheters are indicated for the balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The balloon sizes 2.00-4.00mm are also indicated for post-delivery expansion of balloon expandable stents.

Source page: https://510kreport.com/device/K162625
Methodology: https://510kreport.com/methodology