FIRMAP CATHETER
FDA 510(k) clearance K130827 · decided 2013-10-31
Clearance details
- K-number
- K130827
- Device name
- FIRMAP CATHETER
- Applicant
- Topera, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-03-26
- Decision date
- 2013-10-31
- Days to decision
- 219 days
- Clearance type
- Traditional
- Product code
- MTD
- Device class
- 2
- Regulation number
- 870.1220
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- St.Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F (2.84mm) recall (Z-2478-2015) | Abbott Electrophysiology | 2015-08-28 |