LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR)

System, Perfusion, Kidney

ORGAN RECOVERY SYSTEMS, INC.

The following data is part of a premarket notification filed by Organ Recovery Systems, Inc. with the FDA for Lifeport, Kidney Perfusion Transporter (ktr).

Pre-market Notification Details

Device IDK021362
510k NumberK021362
Device Name:LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR)
ClassificationSystem, Perfusion, Kidney
Applicant ORGAN RECOVERY SYSTEMS, INC. 701 EAST BAY ST. SUITE 433 Charleston,  SC  29403
ContactStanley J Harris
CorrespondentStanley J Harris
ORGAN RECOVERY SYSTEMS, INC. 701 EAST BAY ST. SUITE 433 Charleston,  SC  29403
Product CodeKDN  
CFR Regulation Number876.5880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-04-30
Decision Date2003-07-31

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10815045020268 K021362 000
10815045020565 K021362 000
10815045020473 K021362 000
10815045020459 K021362 000
10815045020435 K021362 000
00815045020391 K021362 000
00815045020377 K021362 000
10815045020336 K021362 000
10815045020312 K021362 000
10815045020275 K021362 000
10815045020251 K021362 000
00815045020001 K021362 000
00815045020018 K021362 000
00815045020032 K021362 000
10815045020244 K021362 000
20815045020241 K021362 000
10815045020206 K021362 000
10815045020183 K021362 000
10815045020169 K021362 000
10815045020121 K021362 000
10815045020107 K021362 000
10815045020084 K021362 000
10815045020145 K021362 000
00815045020049 K021362 000
10815045020237 K021362 000

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