FDA 510(k) Applications Submitted by DEBRA KRIDNER

FDA 510(k) Number Submission Date Device Name Applicant
K000430 02/09/2000 AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH CARMEDA BIOACTIVE SURFACE, MODEL CB511 MEDTRONIC VASCULAR
K960755 02/23/1996 CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS MEDTRONIC CARDIAC SURGERY, MEDTRONIC, INC.
K180640 03/12/2018 SmartClip Soft Tissue Marker Elucent Medical, Inc.
K210836 03/22/2021 InstruSafe Instrument Protection System Summitt Medical LLC
K961836 05/13/1996 MAXIMA FORTE HARDSHELL VENOUS RESERVOIR MEDTRONIC VASCULAR
K962641 07/05/1996 MAXIMA FORTE HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER MEDTRONIC VASCULAR
K222404 08/09/2022 Evo« sEEG System NeuroOne Medical Technologies Corp.
K992910 08/30/1999 AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH BALANCE BIOCOMPATIBLE SURFACE (MODEL 511B) MEDTRONIC VASCULAR
K973475 09/12/1997 CARMEDA COATED CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS (CBCTXXX SERIES AND CBCTXXXBR SERIES) MEDTRONIC VASCULAR
K192764 09/30/2019 NeuroOne Cortical Electrode NeuroOne, Inc.
K183400 12/07/2018 EnVisio Navigation Sytem Elucent Medical, Inc
K955046 11/03/1995 SOFT VENOUS RESERVOIR GISH BIOMEDICAL, INC.


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