Atlas FDA

Intravascular Administration Sets

FDA 510(k) clearance K203609 · decided 2021-09-30

Clearance details

K-number
K203609
Device name
Intravascular Administration Sets
Applicant
Baxter Healthcare Corporation
Decision
Substantially Equivalent
Date received
2020-12-10
Decision date
2021-09-30
Days to decision
294 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
No
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-0192-2026)Baxter Healthcare Corporation2025-10-16
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valv recall (Z-0193-2026)Baxter Healthcare Corporation2025-10-16
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valv recall (Z-0194-2026)Baxter Healthcare Corporation2025-10-16
Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck recall (Z-2594-2025)Baxter Healthcare Corporation2025-09-19
Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519 recall (Z-1011-2025)Baxter Healthcare Corporation2025-01-22

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