Reprocessed Inquiry Steerable Diagnostic EP Catheter— 510(k) K203261
Substantially EquivalentInnovative Health, LLC
FDA 510(k) clearance K203261 for Reprocessed Inquiry Steerable Diagnostic EP Catheter, Substantially Equivalent on 2021-03-05. Applicant: Innovative Health, LLC.
Clearance details
- Applicant
- Innovative Health, LLC
- Product code
- Code DRF
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Scottsdale, AZ, US
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.