K241158
- 510(k) number
- K241158
- Device name
- ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3
- Applicant
- Asahi Intecc Co., Ltd. JP
- Product code
- DQY — Catheter, Percutaneous
- Decision date
- 2024-06-25
- Date received
- 2024-04-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K241158.pdf
Official FDA record: K241158
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.