CARDIMA ABLATION SYSTEM
FDA 510(k) clearance K022008 · decided 2003-01-29
Clearance details
- K-number
- K022008
- Device name
- CARDIMA ABLATION SYSTEM
- Applicant
- Cardima, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-06-19
- Decision date
- 2003-01-29
- Days to decision
- 224 days
- Clearance type
- Traditional
- Product code
- OCL
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Carlos, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device, Mode recall (Z-2580-2010) | Cardima Inc | 2010-09-27 |
| Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device, Mode recall (Z-2581-2010) | Cardima Inc | 2010-09-27 |