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510(k) K021362

LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR) by Organ Recovery Systems, Inc. — Product Code KDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2003
Date Received
April 30, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Perfusion, Kidney
Device Class
Class II
Regulation Number
876.5880
Review Panel
GU
Submission Type

Other clearances by Organ Recovery Systems, Inc.

  • K091656 — SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L (March 11, 2010)
  • K022391 — MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION (October 21, 2002)
  • K013575 — KPS-I, THE KIDNEY PERFUSION SOLUTION (January 25, 2002)

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