Atlas FDA

Solution Administration Sets with 0.2 Micron Filter

FDA 510(k) clearance K153158 · decided 2015-12-28

Clearance details

K-number
K153158
Device name
Solution Administration Sets with 0.2 Micron Filter
Applicant
Baxter Healthcare Corporation
Decision
Substantially Equivalent
Date received
2015-11-02
Decision date
2015-12-28
Days to decision
56 days
Clearance type
Special
Product code
FPA
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Round Lake, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Lu recall (Z-0195-2026)Baxter Healthcare Corporation2025-10-16
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK recall (Z-0196-2026)Baxter Healthcare Corporation2025-10-16

PMA approvals by this applicant

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