K232130
- 510(k) number
- K232130
- Device name
- Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter
- Applicant
- Surgical Instrument Services and Savings, Inc. OR · US
- Product code
- OWQ — Reprocessed Intravascular Ultrasound Catheter
- Decision date
- 2023-12-15
- Date received
- 2023-07-17
- 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: K232130.pdf
Official FDA record: K232130
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.