Pacel Flow Directed Pacing Catheter
FDA 510(k) clearance K161873 · decided 2016-11-22
Clearance details
- K-number
- K161873
- Device name
- Pacel Flow Directed Pacing Catheter
- Applicant
- St Jude Medical
- Decision
- Substantially Equivalent
- Date received
- 2016-07-07
- Decision date
- 2016-11-22
- Days to decision
- 138 days
- Clearance type
- Traditional
- Product code
- LDF
- Device class
- 2
- Regulation number
- 870.3680
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minnetonka, MN, 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 |
|---|---|---|
| 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 |