REVEAL PLUS INSERTABLE LOOP RECORDER
FDA 510(k) clearance K003667 · decided 2001-02-14
Clearance details
- K-number
- K003667
- Device name
- REVEAL PLUS INSERTABLE LOOP RECORDER
- Applicant
- Medtronic Vascular
- Decision
- Substantially Equivalent
- Date received
- 2000-11-28
- Decision date
- 2001-02-14
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- MXC
- Device class
- 2
- Regulation number
- 870.2800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minneapolis, 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.
| 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 |
| myMerlin(TM) Mobile Application Model APP1001 (K173232) | St Jude Medical | 2017-11-02 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System - RX and OTW; Onyx Frontier Zotarolimus-Eluting Coronary Stent S (P160043/S089) | Medtronic Vascular | 2025-12-19 |
| Endurant II/IIs Stent Graft System (P100021/S131) | Medtronic Vascular | 2025-10-23 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S129) | Medtronic Vascular | 2025-09-15 |
| Resolute Onyx (P160043/S088) | Medtronic Vascular | 2025-06-26 |
| Endurant Stent Graft System (P100021/S130) | Medtronic Vascular | 2025-06-12 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S073) | Medtronic Vascular | 2025-06-12 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S072) | Medtronic Vascular | 2025-05-20 |
| Valiant Thoracic Stent Graft with the Captiva Delivery System (P100040/S069) | Medtronic Vascular | 2025-05-08 |