# K060960: Boston Scientific Talon Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Apr 12, 2006 after 5 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- 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: 1 generation back to K000798 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000798: Talon Balloon Dilation Catheter, Boston Scientific Corp (2000) Summary page 1.

## Indications for use
The Boston Scientific Talon Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) of the iliac, femoral, ilio-femoral, popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Source page: https://510kreport.com/device/K060960
Methodology: https://510kreport.com/methodology