K242337
- 510(k) number
- K242337
- Device name
- FlowGuide (FG60F); GuidionShort (GS60F)
- Applicant
- Imds Operations B.V. NL
- Product code
- DQY — Catheter, Percutaneous
- Decision date
- 2025-04-17
- Date received
- 2024-08-07
- 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: K242337.pdf
Official FDA record: K242337
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.