# K151253: 2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Limited
- Decided: Jun 10, 2015 after 29 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: 8 generations back to K904275 (1991). 14 ancestors in all.
1 later device descends 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)
- K041993: 2 CM Peripheral Cutting Baloon, Boston Scientific Ivt (2004) Summary page 4.
- K070951: 2CM Peripheral Cutting Balloon, Small Peripheral Cutting Balloon with Monorail and Over-the-Wire Delivery Systems, Boston Scientific (2007). Our OCR of the scanned summary read K070851, FDA’s number for Arthrocare Spinewands (Arthrocare Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “2cm Peripheral Cutting Balloon® Microsurgical Dilatation Catheter”. Summary page 5.

## Most influential descendants
- K232207: D·Kutting™ PTA Scoring Balloon Dilatation Catheter (2024), 0 descendants of its own

## Indications for use
The Peripheral Cutting Balloon catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.

Source page: https://510kreport.com/device/K151253
Methodology: https://510kreport.com/methodology