# K052038: Peripheral Cutting Balloon Small Monorail or Over-the-Wire Delivery System

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Aug 16, 2005 after 19 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K904275 (1991). 11 ancestors in all.
4 later devices descend from it; 2 cite 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)
- K051254: Peripheral Cutting Balloon, Boston Scientific Ivt (2005) Summary page 4.
- K040155: Peripheral Cutting Balloon, Boston Scientific Corp (2004) Summary page 4.
- K041993: 2 CM Peripheral Cutting Baloon, Boston Scientific Ivt (2004) Summary page 4.

## Most influential descendants
- K062387: Small Peripheral Cutting Ballon, Monorail Delivery System (2006), 3 descendants of its own
- 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

## Recalls of this device
- Dec 7, 2005 · Not classified · Z-0409-06: The distal shaft of the catheter may separate during withdrawal of the device from the patient. If the shaft separates, the surgical procedure may be prolonged or require more in-depth surgery to phys
- Dec 7, 2005 · Not classified · Z-0410-06: The distal shaft of the catheter may separate during withdrawal of the device from the patient. If the shaft separates, the surgical procedure may be prolonged or require more in-depth surgery to phys

## Indications for use
The 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/K052038
Methodology: https://510kreport.com/methodology