Atlas FDA

Clearlink System Solution Set

FDA 510(k) clearance K180739 · decided 2019-05-28

Clearance details

K-number
K180739
Device name
Clearlink System Solution Set
Applicant
Baxter Healthcare Corporation
Decision
Substantially Equivalent
Date received
2018-03-22
Decision date
2019-05-28
Days to decision
432 days
Clearance type
Traditional
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
Yes
Expedited review
No

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Recalls involving this device

RecordFirmDate
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves recall (Z-0201-2026)Baxter Healthcare Corporation2025-10-16
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valv recall (Z-0202-2026)Baxter Healthcare Corporation2025-10-16
CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK L recall (Z-0203-2026)Baxter Healthcare Corporation2025-10-16
Baxter Solution Set with Duo-Vent Spike, REF 2R8404 recall (Z-1009-2025)Baxter Healthcare Corporation2025-01-22
Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538 recall (Z-1010-2025)Baxter Healthcare Corporation2025-01-22
CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401 recall (Z-1291-2024)Baxter Healthcare Corporation2024-03-14

PMA approvals by this applicant

RecordFirmDate
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