K240787
- 510(k) number
- K240787
- Device name
- Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)
- Applicant
- Biotronik, Inc. OR · US
- Product code
- DQY — Catheter, Percutaneous
- Decision date
- 2024-09-12
- Date received
- 2024-03-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K240787.pdf
Official FDA record: K240787
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.