OneStim-DUO Cardiac Stimulator (MP5003-4CO)
FDA 510(k) clearance K253088 · decided 2026-06-12
Clearance details
- K-number
- K253088
- Device name
- OneStim-DUO Cardiac Stimulator (MP5003-4CO)
- Applicant
- Micropace Pty, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-23
- Decision date
- 2026-06-12
- Days to decision
- 262 days
- Clearance type
- Traditional
- Product code
- DQK
- Device class
- 2
- Regulation number
- 870.1425
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Homebush W., AU
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.