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FDA 510(k) Applications Submitted by Integra LifeSciences Production Corporation
FDA 510(k) Number
Submission Date
Device Name
Applicant
K221840
06/24/2022
Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves
Integra LifeSciences Production Corporation
K233445
10/19/2023
Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter
Integra LifeSciences Production Corporation
K233448
10/20/2023
Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set
Integra LifeSciences Production Corporation
K223330
10/31/2022
Certas Plus Programmable Valves
Integra LifeSciences Production Corporation
K232890
09/18/2023
CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)
Integra LifeSciences Production Corporation
K210993
04/02/2021
CereLink ICP Monitor
Integra LifeSciences Production Corporation
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