K241040
- 510(k) number
- K241040
- Device name
- Amethyst HP PTA OTW 0.035 Catheter
- Applicant
- Natec Medical , Ltd. MU
- Product code
- LIT — Catheter, Angioplasty, Peripheral, Transluminal
- Decision date
- 2024-12-18
- Date received
- 2024-04-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K241040.pdf
Official FDA record: K241040
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.