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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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cordis dow c-dak 1.3mrc artif. kidney Cordis Corp. k802893 02/13/1981
clariti 1 day (somofilcon a) soft (hydrophilic) daily disposable contact lens with uv blocker CooperVision, Inc. k181920 12/11/2018
blue rhino g1-multi percutaneous tracheostomy introducer set, blue rhino g1-multi percutaneous tracheostomy introducer tray, blue rhino g2-multi percutaneous tracheostomy introducer set, blue rhino g2-multi percutaneous tracheostomy introducer tray, weinmann-multi percutaneous tracheostomy exchange set Cook Incorporated k193133 12/12/2019
cure catheter insertion kit (k1); cure catheter insertion kit (k2); cure catheter insertion kit (k2-90); cure catheter insertion kit (k3); cure hydrophilic catheter kit (hm12uk); cure hydrophilic catheter kit (hm14uk); cure hydrophilic catheter kit (hm16uk); cure pocket catheter kit (m14uk); cure catheter closed system kit (cs8); cure catheter closed system kit (cs10); cure catheter closed system kit (cs12); cure catheter closed system kit (cs14); cure catheter closed system kit (cs14c Convatec Limited k250891 06/06/2025
contralco Contralco k100879 08/04/2010
enflu 18 (enflufocon a) daily wear contact lens Contamac, Ltd. k171575 10/24/2017
conphar silicone coated foley cath Conphar, Inc. k792111 11/16/1979
concentric balloon guide catheter, model 90031 Concentric Medical, Inc. k010954 10/09/2001
scoville-lewis aneurysm clips Codman & Shurtleff, Inc. k791764 10/01/1979
cns-ep system and ep 1.0 software Cns, Inc. k860240 04/17/1986

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