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510(k) K821056

FLOW DIRECTED THERMAL-DILUTION CATHETER by Oximetrix, Inc.

K821056 is an FDA 510(k) premarket notification submitted by Oximetrix, Inc. for the device "FLOW DIRECTED THERMAL-DILUTION CATHETER". The FDA issued a decision of Substantially Equivalent on May 18, 1982. Oximetrix, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1982
Date Received
April 15, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Oximetrix, Inc.

  • K853018 — MODEL 3000 OPTICATH COMPUTER (January 13, 1986)
  • K842622 — HEMO STATIC/ESU SCALPEL SYSTEM (October 23, 1984)
  • K833966 — PUMP INFUSION WEARABLE INFUSION PUMP (January 25, 1984)
  • K823007 — OPTICATH HEPARIN COATED, FLOW-DIRECT (November 1, 1982)
  • K821057 — FLOW DIRECTED THERMAL-DILUTION INFUSION (May 18, 1982)
  • K820674 — OPTICATH (March 25, 1982)
  • K811391 — OXIMETRIX ACCU SAT CPB (July 20, 1981)
  • K791868 — OXIMETRIX SHAW HEMOSTATIC SURG. SYS. (January 4, 1980)
  • K781879 — HEATER, OXIMETER SYSTEM (January 8, 1979)
  • K781134 — CATHETER, THERMAL DILUTION FIBEROPTIC (August 17, 1978)

FDA data resources