React 68 Catheter— 510(k) K180715
Substantially EquivalentMicro Therapeutics, Inc. d/b/a ev3 Neurovascular
FDA 510(k) clearance K180715 for React 68 Catheter, Substantially Equivalent on 2018-07-04. Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular.
Clearance details
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Product code
- Code DQY
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- 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.