OptiMap Catheter - 60mm (OPTI-CATH2-60)
FDA 510(k) clearance K261012 · decided 2026-04-23
Clearance details
- K-number
- K261012
- Device name
- OptiMap Catheter - 60mm (OPTI-CATH2-60)
- Applicant
- Cortex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2026-03-27
- Decision date
- 2026-04-23
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- MTD
- Device class
- 2
- Regulation number
- 870.1220
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Santa Clara, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.