K254149
- 510(k) number
- K254149
- Device name
- Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485)
- Applicant
- Sterilmed, Inc. MN · US
- Product code
- OWQ — Reprocessed Intravascular Ultrasound Catheter
- Decision date
- 2026-06-29
- Date received
- 2025-12-22
- 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: K254149.pdf
Official FDA record: K254149
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.