Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter— 510(k) K190132
Substantially EquivalentMedtronic
FDA 510(k) clearance K190132 for Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter, Substantially Equivalent on 2019-07-30. Applicant: Medtronic. Device class: 2.
Clearance details
- Applicant
- Medtronic
- Product code
- Code DRF
- Device class
- Class 2
- Regulation
- 21 CFR 870.1220
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mounds View, MN, US
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Adverse events under product code DRF
product code DRF- Death
- 127
- Injury
- 1,676
- Malfunction
- 2,003
- Other
- 1
- Total
- 3,807
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.