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510(k) K843409

FLOW-DIRECTED THERMODILUTION CATH by Andover Medical, Inc. — Product Code DYG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1984
Date Received
August 31, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Flow Directed
Device Class
Class II
Regulation Number
870.1240
Review Panel
CV
Submission Type

Other clearances by Andover Medical, Inc.

  • K905729 — CANMED 451 (February 7, 1991)
  • K903427 — NORTECH MODEL 86901000 ELECTRODE (August 17, 1990)
  • K885171 — MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE (January 12, 1989)
  • K860636 — FASTRACE III, ECG ELECTRODE (May 9, 1986)
  • K854433 — ECG MONITORING/DEFIBRILLATION ELECTRODE (May 8, 1986)
  • K860535 — UNILATERAL OXYGEN DELIVERY SYSTEM (ULODS) (April 1, 1986)
  • K860283 — AMI CARDIO-PAD (March 31, 1986)
  • K843410 — FLOW-DIRECTED PEDIATRIC THERMODIL- CATH (November 20, 1984)
  • K843412 — FLOW DIRECTED THERMODILUTION CATH W/VEN (November 20, 1984)
  • K843411 — THERMAL DILUTION CATHETER (October 18, 1984)

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  • K081052 — OCCLUSION BALLOON CATHETER, MODEL VENOS (June 18, 2008)
  • K010253 — ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ (March 19, 2002)