myMerlin(TM) Mobile Application Model APP1001
FDA 510(k) clearance K173232 · decided 2017-11-02
Clearance details
- K-number
- K173232
- Device name
- myMerlin(TM) Mobile Application Model APP1001
- Applicant
- St Jude Medical
- Decision
- Substantially Equivalent
- Date received
- 2017-10-04
- Decision date
- 2017-11-02
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- MXC
- Device class
- 2
- Regulation number
- 870.2800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Sylmar, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch St Jude Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Assert-IQ™ Insertable Cardiac Monitor (K230286) | ABBOTT MEDICAL | 2023-05-17 |
| Jot Dx Insertable Cardiac Monitor (K212206) | Abbott (St. Jude Medical) | 2021-08-13 |
| Confirm Rx Insertable Cardiac Monitor (K202876) | Abbott (St. Jude Medical) | 2020-12-01 |
| Confirm Rx Insertable Cardiac Monitor (K202888) | Abbott (St. Jude Medical) | 2020-11-23 |
| myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) (K193310) | Abbott (St. Jude Medical) | 2020-03-17 |
| Confirm Rx Insertable Cardiac Monitor (K192593) | Abbott | 2019-10-18 |
| Confirm Rx Insertable Cardiac Monitor (K190295) | Abbott (St. Jude Medical) | 2019-04-10 |
| Confirm Rx Insertable Cardiac Monitor (K182981) | Abbott | 2019-03-29 |
| Confirm Rx Insertable Cardiac Monitor (ICM) System (K163407) | St. Jude Medical, Inc. | 2017-09-29 |
| SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM) (K133481) | St. Jude Medical, Inc. | 2014-05-28 |
| SJM CONFIRM (K122161) | St Jude Medical | 2012-11-28 |
| SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (K122090) | St. Jude Medical, Cardiac Rhythm Management Divisi | 2012-11-15 |
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 |