# K093720: Sterling SL Monorail Pta Balloon Dilatation Catheters Sterling SL Over-the-Wire Balloon Dilatation Catheters Model Vario

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Dec 23, 2009 after 21 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: 5 generations back to K001134 (2000). 6 ancestors in all.
21 later devices descend from it; 4 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080982: Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation Catheters, Boston Scientific Corp (2008) Summary page 1.
- K053118: Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-Xxxxxx, Boston Scientific Corp (2005) Summary page 1.
- K053116: Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx, Boston Scientific Corp (2005) Summary page 1.
- (no number) Polarcath Peripheral Dilatation System: named in the summary without a submission number

## Most influential descendants
- K111295: .014 Monorail and Otw Pta Balloon Dilatation Catheters (2011), 9 descendants of its own
- K141150: Pta Balloon Dilatation Catheter (2014), 8 descendants of its own
- K173894: Jade PTA Balloon Dilatation Catheter (2018), 3 descendants of its own
- K140351: Arrow Gpscath Balloon Dilatation Catheter (2014), 3 descendants of its own
- K120805: Proteus Pta Balloon Catheter with Embolic Capture Feature (2012), 3 descendants of its own

## Indications for use
Sterling SL PTA Balloon Dilatation Catheter is indicated for Percutaneous Trarisluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, ilio-femnoral, infrapc'pliteal, popliteal, renal arteries, and for the treatment of obstructive lesions c::f native or synthetic arteriovenous dialysis fistulae.

Source page: https://510kreport.com/device/K093720
Methodology: https://510kreport.com/methodology