# K011889: Ultra -Thin SDS Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Dec 21, 2001 after 186 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: 1 generation back to K972744 (1997). 1 ancestor in all.
20 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972744: Courier ST Balloon Dilatation Catheter, Boston Scientific Corp (1997) Summary page 1.

## Most influential descendants
- K082339: Enabler-P Support Catheter (2008), 14 descendants of its own
- K083833: Enabler-P Catheter, 1000 Part Number:1160 (2009), 12 descendants of its own
- K092174: Enabler-P Catheter System, Model 3000 (2009), 9 descendants of its own
- K121763: Multicross Support Catheter (2012), 8 descendants of its own
- K021630: Boston Scientific Express Biliary LD Premounted Stent System (2002), 4 descendants of its own

## Indications for use
Ultra-Thin SDS Balloon Dilatation Catheters are recommended for percutaneous transluminal angioplasty of the iliac, femoral, ilio-femoral, popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Source page: https://510kreport.com/device/K011889
Methodology: https://510kreport.com/methodology