FDA 510(k) Applications Submitted by Gayatri Ghadge

FDA 510(k) Number Submission Date Device Name Applicant
K220420 02/14/2022 Saffron Fixation System Coloplast A/S
K170583 02/28/2017 Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface Medtronic, Inc.
K221874 06/28/2022 Altis Single Incision Sling System Coloplast A/S
K213185 09/29/2021 ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits Coloplast Corp
K213186 09/29/2021 NovoFlow Reinforced Ureteral Stent Coloplast Corp


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