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510(k) K921550

LIFESTREAM CENTRIFUGAL PUMP SYSTEM MODEL 2100CP by St. Jude Medical, Inc. — Product Code KFM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1992
Date Received
March 24, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Device Class
Class II
Regulation Number
870.4360
Review Panel
CV
Submission Type

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  • K140793 — NANOSTIM INTRODUCER KIT (December 17, 2014)
  • K133481 — SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM) (May 28, 2014)
  • K131592 — ENLIGHTN RENAL GUIDE CATHETER (January 31, 2014)
  • K073700 — 6F PROXIS SYSTEM (October 2, 2008)
  • K042734 — SJM RIGID SADDLE RING MODEL RSAR-(SIZE) (December 17, 2004)

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