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510(k) K884318

THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM by Abbott Laboratories — Product Code KRB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 1988
Date Received
October 13, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Thermodilution
Device Class
Class II
Regulation Number
870.1915
Review Panel
CV
Submission Type

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  • K936182 — CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT (March 25, 1994)
  • K915627 — PACEVIEW (March 27, 1992)
  • K912172 — SAFEWEDGE(TM) RELIEF VALVE DEVICE (September 27, 1991)
  • K902627 — INTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH. (February 25, 1991)
  • K900710 — INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER (October 19, 1990)