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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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safe maxi venous/cardiotomy reservior, model 016045 POLYSTAN A/S k022281 08/06/2002
endovive initial placement direct pej kit, endovive standard profile balloon replacement, models 6520, 6521, 6220 BOSTON SCIENTIFIC CORP. k020120 08/02/2002
trz-cg power positioning system with center-of-gravity shifting power tilt, recline, and power elevating seat MOTION CONCEPTS k021264 07/30/2002
modification to en-bloc biopsy system NEOTHERMIA CORP. k022296 07/30/2002
codman bactiseal evd catheter set Codman & Shurtleff, Inc. k021653 07/29/2002
xtd thrombectomy catheter, xx cm XTRAK MEDICAL INC. k021641 07/26/2002
novabone-resorbable bone graft substitute NovaBone Products, LLC k021336 07/25/2002
k-assay lp(a) assay KAMIYA BIOMEDICAL CO. k021660 07/25/2002
stat profile phox plus c analyzer NOVA BIOMEDICAL CORP. k021713 07/25/2002
auropal 60 WIELAND DENTAL + TECHNIK GMBH & CO. KG k021926 07/25/2002

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