K232258
- 510(k) number
- K232258
- Device name
- XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter
- Applicant
- Transit Scientific, LLC UT · US
- Product code
- PNO — Catheter, Percutaneous, Cutting/Scoring
- Decision date
- 2024-06-17
- Date received
- 2023-07-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K232258.pdf
Official FDA record: K232258
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.