Home / 510(k) Clearances / K971571

510(k) K971571

RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT by Waters Instruments, Inc. — Product Code KDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1997
Date Received
April 30, 1997
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 Waters Instruments, Inc.

  • K053169 — RM3 RENAL PRESERVATION SYSTEM (January 17, 2006)
  • K042224 — RM3 RENAL PRESERVATION SYSTEM (October 22, 2004)
  • K921519 — OXICOM-2100 (October 23, 1992)
  • K911207 — OXICOMPLUS (August 26, 1991)
  • K863210 — VELCOM-100 (November 26, 1986)
  • K862161 — OSC-80 OXIMETER (August 18, 1986)
  • K852909 — MVP - 6000 (November 14, 1985)
  • K834408 — TX-2 THERMAL DILUTION CARDIAC OUTPUT (August 23, 1984)
  • K841876 — POLYURETHANE THERMAL DILUTION CATHET (July 13, 1984)
  • K813585 — WATERS ILEOSTOMY VALVE (April 9, 1982)

Other clearances for product code KDN

  • K260456 — VI°Port™ Liver Preservation System (June 1, 2026)
  • K254305 — BAROguard Donor Lung Preservation System (January 30, 2026)
  • K243618 — EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) (June 17, 2025)
  • K243870 — X°Port Lung Preservation System; X°Port Lung Preservation Solution (May 1, 2025)
  • K243998 — DCX Disposable Cassette (DCX) (April 25, 2025)
  • K243384 — Belzer UW® Cold Storage Solution (BTLBUW-001) (March 31, 2025)
  • K243840 — Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) (March 26, 2025)
  • K240650 — LungProtect (November 26, 2024)
  • K234060 — KIDNEYvault Portable Renal Perfusion System (October 23, 2024)
  • K230193 — Servator P Plus SALF Solution (September 21, 2023)