K242969
- 510(k) number
- K242969
- Device name
- Pantera Pro; Pantera LEO
- Applicant
- Biotronik, Inc. OR · US
- Product code
- LOX — Catheters, Transluminal Coronary Angioplasty, Percut
- Decision date
- 2024-10-25
- Date received
- 2024-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K242969.pdf
Official FDA record: K242969
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.