Atlas FDA

SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE

FDA 510(k) clearance K003225 · decided 2000-10-19

Clearance details

K-number
K003225
Device name
SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE
Applicant
Baxter Healthcare Corp
Decision
Substantially Equivalent
Date received
2000-10-16
Decision date
2000-10-19
Days to decision
3 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
Baxter Clearlink System Non-DEHP Y-Type Catheter Extension Set, 6.5" (16.5 cm), Vol 1.2 mL recall (Z-0148-2011)Baxter Healthcare Corp.2010-10-27
Baxter Catheter Extension Set, Luer Activated Valve for I.V. Access, Male Luer Lock Adapte recall (Z-0158-2011)Baxter Healthcare Corp.2010-10-27
Baxter Clearlink System Vented Paclitaxel Set; a sterile fluid pathway with polyethylene l recall (Z-0618-2007)Baxter Healthcare Corp.2007-03-14
Baxter Interlink System Non-DEHP Y-Type Catheter Extension Set, product code 2N8371; An Rx recall (Z-0625-06)Baxter Healthcare Corp.2006-03-24
Baxter Clearlink System Non-DEHP Minivolume Extension Set, product code 1C8705; An Rx ster recall (Z-0650-06)Baxter Healthcare Corp.2006-03-24
Baxter Clearlink System Non-DEHP Minivolume Extension Set, product code 1C8739; An Rx ster recall (Z-0651-06)Baxter Healthcare Corp.2006-03-24
Baxter ClearLink Intravenous (IV) Solution Sets and Extension Sets that have a ClearLink l recall (Z-0845-05)Baxter Healthcare Corp.2005-05-17
Baxter Clearlink Intravenous (IV) Delivery System; the system consists of solution sets, e recall (Z-0193-05)Baxter Healthcare Corp.2004-11-16
Continu-Flo Solution Set, 10 drops/mL, 113'', 2 Luer Activated Valves, Male Luer Lock Adap recall (Z-1070-03)Baxter Healthcare Corp.2003-08-21
Clearlink System Continu-Flo Solution Set, 10 drops/mL, 113'', 2 Luer Activated Valves, Ma recall (Z-1156-03)Baxter Healthcare Corp.2003-08-21
Clearlink System Nitroglycerin Set with DUO-VENT Spike, 60 drops/mL, 105'', PVC Tubing Seg recall (Z-1157-03)Baxter Healthcare Corp.2003-08-21
Clearlink System Vented Paclitaxel Set, 10 drops/mL, 111'', Polyethylene Lined Tubing, Non recall (Z-1158-03)Baxter Healthcare Corp.2003-08-21
Continu-Flo Solution Set, 60 drops/mL, 106'', 3 Luer Activated Valves, Male Luer Lock Adap recall (Z-1159-03)Baxter Healthcare Corp.2003-08-21
Clearlink System Y-Type Blood/Solution Set, 10 drops/mL, 112'', Standard Blood Filter, 170 recall (Z-1161-03)Baxter Healthcare Corp.2003-08-21
Baxter Solution Set, 10 drops/mL, 76'', Luer Activated Valve, Male Luer Lock Adapter, cata recall (Z-1166-03)Baxter Healthcare Corp.2003-08-21
Baxter Solution Set, 60 drops/mL, 76'', Luer Activated Valve, Male Luer Lock Adapter, cata recall (Z-1167-03)Baxter Healthcare Corp.2003-08-21
Vented Solution Set, 10 drops/mL, 92'', Luer Activated Valve, Male Luer Lock Adapter, cata recall (Z-1168-03)Baxter Healthcare Corp.2003-08-21
Continu-Flo Solution Set, 10 drops/mL, 110'', 3 Luer Activated Valves, Male Luer Lock Adap recall (Z-1169-03)Baxter Healthcare Corp.2003-08-21

PMA approvals by this applicant

RecordFirmDate
Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (P990009/S077)Baxter Healthcare Corp2025-11-13
FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (P990009/S076)Baxter Healthcare Corp2025-06-30
Floseal Hemostatic Matrix (P990009/S075)Baxter Healthcare Corp2025-01-30
Adept Adhesion Reduction Solution (P050011/S009)Baxter Healthcare Corp2024-08-23
Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep (P990009/S074)Baxter Healthcare Corp2024-08-15
Floseal Hemostatic Matrix (P990009/S073)Baxter Healthcare Corp2024-01-10
Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RTS (P990009/S072)Baxter Healthcare Corp2023-12-12
Floseal Hemostatic Matrix, RT5 (P990009/S070)Baxter Healthcare Corp2023-02-02