Sterling MONORAIL PTA Balloon Dilatation Catheter (6+ models)— 510(k) K241683

Clearance details

Device name as filed

Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031406020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031408020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031410020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031412020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031415020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H749390314

Applicant

Boston Scientific Corporation

Product code

Code LIT

Device class

Class 2

Regulation

21 CFR 870.1250

Advisory panel

Cardiovascular

Date received

2024-06-11

Decision date

2024-07-10

Decision

Substantially Equivalent

Clearance type

Special

Location

Maple Grove, MN, US

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Death

27

Injury

1,256

Malfunction

12,127

Total

13,410

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →