K232578
- 510(k) number
- K232578
- Device name
- VASSALLO GT 018 G12; VASSALLO GT 018 G30
- Applicant
- Filmec Co. , Ltd. JP
- Product code
- DQX — Wire, Guide, Catheter
- Decision date
- 2023-10-11
- Date received
- 2023-08-25
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K232578.pdf
Official FDA record: K232578
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.