React 68 Catheter
FDA 510(k) clearance K180715 · decided 2018-07-04
Clearance details
- K-number
- K180715
- Device name
- React 68 Catheter
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Decision
- Substantially Equivalent
- Date received
- 2018-03-19
- Decision date
- 2018-07-04
- Days to decision
- 107 days
- Clearance type
- Traditional
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.