Atlas FDA

Sentry IVC filter

FDA 510(k) clearance K162875 · decided 2017-02-17

Clearance details

K-number
K162875
Device name
Sentry IVC filter
Applicant
Novate Medical , Ltd.
Decision
Substantially Equivalent
Date received
2016-10-14
Decision date
2017-02-17
Days to decision
126 days
Clearance type
Traditional
Product code
DTK
Device class
2
Regulation number
870.3375
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Galway, IE
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.