K232261
- 510(k) number
- K232261
- Device name
- TME Temporary Myocardial Electrode
- Applicant
- Osypka AG DE
- Product code
- LDF — Electrode, Pacemaker, Temporary
- Decision date
- 2024-04-26
- Date received
- 2023-07-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K232261.pdf
Official FDA record: K232261
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.