REVEAL XT; INSERTABLE CARDIAC MONITOR (MODEL 9529), PATIENT ASSISTANT (MODEL 9539)
FDA 510(k) clearance K071641 · decided 2007-11-21
Clearance details
- K-number
- K071641
- Device name
- REVEAL XT; INSERTABLE CARDIAC MONITOR (MODEL 9529), PATIENT ASSISTANT (MODEL 9539)
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-06-15
- Decision date
- 2007-11-21
- Days to decision
- 159 days
- Clearance type
- Traditional
- Product code
- DSI
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mounds View, MN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Medtronic
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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 |
|---|---|---|
| BodyGuardian Remote Monitoring System (BGRMS v3.0) (K243349) | Boston Scientific Cardiac Diagnostic Technologies, Inc. | 2026-01-23 |
| MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) (K250356) | Infobionic, Inc. | 2025-07-29 |
| Zio AT® device (A100A1001) (K240177) | iRhythm Technologies, Inc. | 2024-10-30 |
| MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System (K230265) | Infobionic, Inc. | 2023-10-06 |
| SmartCardia 7L Platform (K231276) | Smartcardia SA | 2023-08-30 |
| Unified Arrhythmia Diagnostic System PocketECG IV (K193104) | Medicalgorithmics S.A. | 2020-04-09 |
| BodyGuardian Remote Monitoring System (K192732) | Preventice Technologies, Inc. | 2020-03-26 |
| Patient Assistant Model PA97000 (K190574) | Medtronic, Inc. | 2019-09-24 |
| Liba3 System (K182532) | National Cardiac, Inc. | 2019-05-15 |
| MobileECG 2 BT (K181658) | Memtec Corporation | 2019-03-26 |
| Medicalgorithmics Unified Cardiac Rehabilitation System (K173969) | Medicalgorithmics S.A. | 2018-07-11 |
| Epicardia Anywhere (K173170) | Medicomp, Inc. | 2018-01-10 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SynchroMed Infusion System; Ascenda Intrathecal Catheters (P860004/S459) | Medtronic, Inc. | 2026-08-08 |
| Activa Deep Brain Stimulation Therapy System; Percept PC BrainSense (P960009/S540) | Medtronic, Inc. | 2026-08-08 |
| Sphere-9 Catheter AFR-00001 (P240013/S030) | Medtronic, Inc. | 2026-08-06 |
| Sphere-9 Catheter and Affera Ablation System (P240013/S029) | Medtronic, Inc. | 2026-08-04 |
| Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1TR02); Serena Quadripolar (P010015/S589) | Medtronic, Inc. | 2026-07-31 |
| Adapta, Versa, Sensia IPG (ADDR03, ADDRL1, ADDRS1, ADSR01, ADSR03, SED01, SES01, SESR01), Adapta, Versa, Sensia IPG (SED (P980035/S846) | Medtronic, Inc. | 2026-07-31 |
| Aurora EV ICD (DVEA3E4) (P220012/S074) | Medtronic, Inc. | 2026-07-31 |
| Micra AV TPS (MC1AVR1); Micra AV2 TPS (MC2AVR1); Micra TPS (MC1VR01); Micra VR2 TPS (MC2VR01) (P150033/S229) | Medtronic, Inc. | 2026-07-31 |