K242419
- 510(k) number
- K242419
- Device name
- 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
- Applicant
- Creagh Medical Ltd. Dba Surmodics, Inc. IE
- Product code
- LIT — Catheter, Angioplasty, Peripheral, Transluminal
- Decision date
- 2024-11-15
- Date received
- 2024-08-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K242419.pdf
Official FDA record: K242419
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.