K240864
- 510(k) number
- K240864
- Device name
- PacePro Wire
- Applicant
- Opsens, Inc. CA
- Product code
- DQX — Wire, Guide, Catheter
- Decision date
- 2024-05-24
- Date received
- 2024-03-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K240864.pdf
Official FDA record: K240864
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.