K242597
- 510(k) number
- K242597
- Device name
- CROSSLEAD 0.018inch
- Applicant
- Asahi Intecc Co., Ltd. JP
- Product code
- DQX — Wire, Guide, Catheter
- Decision date
- 2025-03-05
- Date received
- 2024-08-30
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K242597.pdf
Official FDA record: K242597
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.