# K040155: Peripheral Cutting Balloon

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Jul 1, 2004 after 160 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: 3 generations back to K904275 (1991). 8 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960501: Ultra-Thin Diamond Balloon Dilatation Catheter, Boston Scientific Corp (1996) Summary page 4.
- K022061: Cvsi Peripheral Balloon Catheter; Cvsi Inflater, Cryo Vascular Systems, Inc. (2002) Summary page 4.
- K030742: Polarcath Peripheral Balloon Catheter System, Cryo Vascular Systems, Inc. (2003) Summary page 4.

## Most influential descendants
- K041993: 2 CM Peripheral Cutting Baloon (2004), 5 descendants of its own
- K052038: Peripheral Cutting Balloon Small Monorail or Over-the-Wire Delivery System (2005), 4 descendants of its own
- 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

## Indications for use
The Peripheral Cutting Balloon™ catheters are indicated for Percutaneous Transluminal Angioplasty of obstructive lesions of synthetic arteriovenous dialysis fistulae.

Source page: https://510kreport.com/device/K040155
Methodology: https://510kreport.com/methodology