CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE)
FDA 510(k) clearance K042850 · decided 2006-08-09
Clearance details
- K-number
- K042850
- Device name
- CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE)
- Applicant
- Stereotaxis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-10-15
- Decision date
- 2006-08-09
- Days to decision
- 663 days
- Clearance type
- Traditional
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Saint Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MAGiC Ablation Catheter (P240014/S001) | Stereotaxis, Inc. | 2026-07-31 |
| MAGiC Ablation Catheter (P240014) | Stereotaxis, Inc. | 2026-01-05 |
| HELIOS II ABLATION CATHETER (P050029) | Stereotaxis, Inc. | 2008-10-10 |