K241683
- 510(k) number
- K241683
- Device name
- 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 MN · US
- Product code
- LIT — Catheter, Angioplasty, Peripheral, Transluminal
- Decision date
- 2024-07-10
- Date received
- 2024-06-11
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.7 MB · U.S. public domain
Also available from FDA: K241683.pdf
Official FDA record: K241683
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.