Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm
FDA 510(k) clearance DEN150049 · decided 2016-09-02
Clearance details
- K-number
- DEN150049
- Device name
- Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm
- Applicant
- Concentric Medical, Inc.
- Decision
- Unknown
- Date received
- 2015-10-26
- Decision date
- 2016-09-02
- Days to decision
- 312 days
- Clearance type
- Direct
- Product code
- POL
- Device class
- 2
- Regulation number
- 882.5600
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.