# K050389: Ultra-Soft SV Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: May 25, 2005 after 99 days
- Product code: DQY (Catheter, Percutaneous)
- 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: 2 generations back to K001134 (2000). 2 ancestors in all.
164 later devices descend from it; 3 cite it directly.
0 of 167 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021735: Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter, Boston Scientific Scimed, Inc. (2002) Summary page 1.

## Most influential descendants
- K053116: Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx (2005), 133 descendants of its own
- K072283: Dorado Pta Balloon Dilatation Catheter (2007), 96 descendants of its own
- K053118: Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-Xxxxxx (2005), 62 descendants of its own
- K083657: Conquest Pta Balloon Dilatation Catheter (2008), 44 descendants of its own
- K103459: Vascutrak Pta Dilatation Catheter (2010), 36 descendants of its own

## Indications for use
The Ultra-soft TM SV Balloon Dilatation Catheters are indicated for percutaneous transluminal angioplasty (PTA) of the carotid, 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/K050389
Methodology: https://510kreport.com/methodology