CPS AIM INNER CATHETER, MODELS 410140, 410141, 410142, 410144, 410145, 410146, 410147, 410148
FDA 510(k) clearance K053217 · decided 2006-03-08
Clearance details
- K-number
- K053217
- Device name
- CPS AIM INNER CATHETER, MODELS 410140, 410141, 410142, 410144, 410145, 410146, 410147, 410148
- Applicant
- St Jude Medical
- Decision
- Substantially Equivalent
- Date received
- 2005-11-17
- Decision date
- 2006-03-08
- Days to decision
- 111 days
- Clearance type
- Traditional
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Sylmar, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CPS Slitter, Model 410191 recall (Z-1164-06) | St Jude Medical CRMD | 2006-06-24 |
| CPS Valve Bypass Tool (VBT), Model 410192 recall (Z-1165-06) | St Jude Medical CRMD | 2006-06-24 |
| CPS Direct SL, Models 410110, 410111, 410112, 410113, 410114, 410115, 410116, 410120, 4101 recall (Z-1166-06) | St Jude Medical CRMD | 2006-06-24 |
| CPS Aim, Models 410140, 410141, 410142, 410144, 410145, 410146, 410147, & 410148 recall (Z-1167-06) | St Jude Medical CRMD | 2006-06-24 |
| CPS Implant Kit, Model 410190 recall (Z-1168-06) | St Jude Medical CRMD | 2006-06-24 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S096) | St Jude Medical | 2025-12-23 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S094) | St Jude Medical | 2025-06-20 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S095) | St Jude Medical | 2025-05-06 |
| Safire Bi-Directional Ablation Catheter; Safire Catheter Extension Cable (P960016/S092) | St Jude Medical | 2025-04-10 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S093) | St Jude Medical | 2025-04-10 |
| TactiCath Ablation Catheter, Sensor Enabled (TactiCath SE) (P130026/S092) | St Jude Medical | 2024-11-27 |
| TactiCath Ablation Catheter, Sensor Enabled (P130026/S091) | St Jude Medical | 2024-11-22 |
| TactiCath Contact Force Ablation Catheter (P130026/S090) | St Jude Medical | 2024-10-09 |