React 71 Catheter— 510(k) K241177
Substantially EquivalentMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular
FDA 510(k) clearance K241177 for React 71 Catheter, Substantially Equivalent on 2024-05-28. Applicant: Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular.
Clearance details
- Applicant
- Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular
- Product code
- Code DQY
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Irvine, CA, US
Adverse events under product code DQY
product code DQY- Death
- 464
- Injury
- 4,489
- Malfunction
- 13,721
- Other
- 2
- Total
- 18,676
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.