ClotTriever Thrombectomy System
FDA 510(k) clearance K180329 · decided 2018-04-09
Clearance details
- K-number
- K180329
- Device name
- ClotTriever Thrombectomy System
- Applicant
- Inari Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-02-06
- Decision date
- 2018-04-09
- Days to decision
- 62 days
- Clearance type
- Special
- Product code
- QEW
- Device class
- 2
- Regulation number
- 870.5150
- 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.