DTGClass I
Magnet, Test, Pacemaker
Cardiovascular · 21 CFR 870.3690
MDR events11All time
Recalls0All time
Registered firms6Currently listed
510(k) clearances5All time
Recent MDR events
11 adverse event reports on file
- MEDTRONIC SLITTERSep 24, 2024MalfunctionMedtronic, Inc.2182208-2024-04099
- MAGNETJan 30, 2024MalfunctionMicroport Crm S.r.l.1000165971-2024-00079
- MAGNETJan 30, 2024MalfunctionMicroport Crm S.r.l.1000165971-2024-00080
- MEDTRONIC SLITTEROct 3, 2023MalfunctionMedtronic Ireland9612164-2023-04448
- MEDTRONIC SLITTEROct 13, 2021MalfunctionMedtronic, Inc.2182208-2021-04077
- MEDTRONIC SLITTERAug 15, 2019MalfunctionMedtronic, Inc.2182208-2019-01501
- MAGNET, TEST, PACEMAKERApr 10, 2019MalfunctionMedtronic, Inc.2182208-2019-00674
- RX PACING LEADSep 27, 2018InjuryOscor Inc1035166-2018-00057
- MAGNET, TEST, PACEMAKEROct 1, 2015MalfunctionMedtronic, Inc.2182208-2015-03242
- MAGNET, TEST, PACEMAKERAug 5, 2015MalfunctionMedtronic, Inc.2182208-2015-02448
Event type breakdown
Malfunction9
Injury2
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
6 firms currently registered for this product code
510(k) clearances
5 clearances for this product code
- Cyberonics, Inc.Nov 3, 2009
K092364 · MODEL 220 PATIENT MAGNET
- Cardiac Assist Devices, Inc.Mar 26, 1997
K960849 · MAGNO ALARM
- Cardiac Control Systems, Inc.Sep 26, 1989
K895110 · MAESTRO PACEMAKER TEST MAGNET
- Oscor, Inc.Mar 12, 1984
K831926 · IMPLANTABLE ENDOCARDIAL PACING LEADS
- Pacesetter SystemsDec 2, 1981
K813153 · TEST MAGNET