FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OptiMap Catheter - 60mm (OPTI-CATH2-60)
K Number: K261012
·
Decision Apr 23, 2026
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
33
Applicant Total
2
Review Days
27
Basic Information
- Device Name
- OptiMap Catheter - 60mm (OPTI-CATH2-60)
- K Number
- K261012
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1220
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cortex, Inc.
- Date Received
- March 27, 2026
- Decision Date
- April 23, 2026
- Product Code
- MTD
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MTD | Catheter, Intracardiac Mapping, High-Density Array | FDA class 2 | Cardiovascular |
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Other Clearances by Cortex, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253205 | OptiMap Catheter - 50mm (OPTI-CATH2-50) | Mar 13, 2026 | Substantially Equivalent |