Atlas FDA

CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS

FDA 510(k) clearance K112893 · decided 2011-10-18

Clearance details

K-number
K112893
Device name
CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS
Applicant
Baxter Healthcare Corporation
Decision
Substantially Equivalent
Date received
2011-10-03
Decision date
2011-10-18
Days to decision
15 days
Clearance type
Special
Product code
FPA
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Mcgaw Park, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-i recall (Z-0190-2026)Baxter Healthcare Corporation2025-10-16
CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/m recall (Z-0191-2026)Baxter Healthcare Corporation2025-10-16
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer recall (Z-0197-2026)Baxter Healthcare Corporation2025-10-16
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer recall (Z-0198-2026)Baxter Healthcare Corporation2025-10-16
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer recall (Z-0199-2026)Baxter Healthcare Corporation2025-10-16
Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. A recall (Z-1653-2022)Baxter Healthcare Corporation2022-09-14
Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 mL, Luer Acti recall (Z-0099-2014)Baxter Healthcare Corp.2013-10-29
A) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0", Vol. 1.0 mL, 2 L recall (Z-1271-2013)Baxter Healthcare Corp.2013-05-07

PMA approvals by this applicant

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Preveleak Surgical Sealant (P100030/S021)Baxter Healthcare Corporation2025-07-10
PerClot® Polysaccharide Hemostatic System (P210036/S005)Baxter Healthcare Corporation2025-04-25
Preveleak Surgical Sealant 4mL; Preveleak Delivery Tips 10 PK (P100030/S020)Baxter Healthcare Corporation2025-04-11
PerClot Polysaccharide Hemostatic System (P210036/S002)Baxter Healthcare Corporation2024-12-20
Seprafilm Adhesion Barrier (P950034/S059)Baxter Healthcare Corporation2024-12-19
PerClot Polysaccharide Hemostatic System (P210036/S004)Baxter Healthcare Corporation2024-07-18
Seprafilm Adhesion Barrier (P950034/S058)Baxter Healthcare Corporation2024-07-03
Preveleak Surgical Sealant, Preveleak 10-Pack delivery Tips (P100030/S019)Baxter Healthcare Corporation2024-06-06