# K062387: Small Peripheral Cutting Ballon, Monorail Delivery System

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific
- Decided: Oct 5, 2006 after 51 days
- Product code: PNO (Catheter, Percutaneous, Cutting/Scoring)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K904275 (1991). 12 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052038: Peripheral Cutting Balloon Small Monorail or Over-the-Wire Delivery System, Boston Scientific Corporation (2005) Summary page 4.

## Most influential descendants
- K070951: 2CM Peripheral Cutting Balloon, Small Peripheral Cutting Balloon with Monorail and Over-the-Wire Delivery Systems (2007), 2 descendants of its own
- K151253: 2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter (2015), 1 descendant of its own
- K232207: D·Kutting™ PTA Scoring Balloon Dilatation Catheter (2024), 0 descendants of its own

## Indications for use
The Small Peripheral Cutting Balloon catheters are indicated for percutaneous transluminal angioplasty of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.

Source page: https://510kreport.com/device/K062387
Methodology: https://510kreport.com/methodology