Atlas FDA

Actifuse Flow

FDA 510(k) clearance K181306 · decided 2018-08-17

Clearance details

K-number
K181306
Device name
Actifuse Flow
Applicant
Baxter Healthcare Corporation
Decision
Substantially Equivalent
Date received
2018-05-17
Decision date
2018-08-17
Days to decision
92 days
Clearance type
Special
Product code
MQV
Device class
2
Regulation number
888.3045
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Round Lake, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

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Seprafilm Adhesion Barrier (P950034/S059)Baxter Healthcare Corporation2024-12-19
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