Atlas FDA

Trevo XP ProVue Retriever

FDA 510(k) clearance K190779 · decided 2019-06-25

Clearance details

K-number
K190779
Device name
Trevo XP ProVue Retriever
Applicant
Stryker
Decision
Substantially Equivalent
Date received
2019-03-27
Decision date
2019-06-25
Days to decision
90 days
Clearance type
Traditional
Product code
POL
Device class
2
Regulation number
882.5600
Medical specialty
Neurology
Advisory committee
Neurology
Location
Fremont, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM); 90185 (4MM x 30MM); 90186 (6MM recall (Z-0114-2021)Stryker Neurovascular2020-10-21