# K121667: NC Quantum Apex Ptca Dilatation Catheter (Monorail)

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Aug 13, 2012 after 68 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 P860019 (1986). 1 ancestor in all.
8 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P860019: Scimed Ptca Dilatation Catheter, Scimed Life Systems, Inc. (1986) Summary page 1.

## Most influential descendants
- K141236: NC Emerge Ptca Dilatation Catheter (Monorail), NC Emerge Ptca Dilatation Catheter (Over-the-Wire) (2014), 3 descendants of its own
- K162434: NC Gallant PTCA Catheter (2017), 1 descendant of its own
- K223189: Firefighter™ NC Pro PTCA Balloon Catheter (2023), 0 descendants of its own
- K222538: NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter (2022), 0 descendants of its own
- K211393: Selethru (TM) NC PTCA Balloon Dilatation Catheter (2021), 0 descendants of its own

## Indications for use
The NC Quantum Apex Monorail PTCA Dilatation Catheters are indicated for the balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. NC Quantum Apex Monorail PTCA Dilatation Catheters are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting).

Source page: https://510kreport.com/device/K121667
Methodology: https://510kreport.com/methodology