Cleared Special

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

K241683 · Boston Scientific Corporation · Cardiovascular

Jul 2024

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K241683 is an FDA 510(k) clearance for the 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, a Catheter, Angioplasty, Peripheral, Transluminal (Class II — Special Controls, product code LIT), submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on July 10, 2024, 29 days after receiving the submission on June 11, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K241683 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 11, 2024
Decision Date	July 10, 2024
Days to Decision	29 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF