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510(k) K820674

OPTICATH by Oximetrix, Inc. — Product Code DQE

K820674 is an FDA 510(k) premarket notification submitted by Oximetrix, Inc. for the device "OPTICATH". The FDA issued a decision of Substantially Equivalent on March 25, 1982. The device falls under product code DQE (Catheter, Oximeter, Fiber-Optic), a Class II device regulated under 21 CFR 870.1230. Oximetrix, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1982
Date Received
March 11, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Oximeter, Fiber-Optic
Device Class
Class II
Regulation Number
870.1230
Review Panel
CV
Submission Type

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)
  • K821056 — FLOW DIRECTED THERMAL-DILUTION CATHETER (May 18, 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)

Other clearances for product code DQE

  • K172423 — PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Ce (February 20, 2018)
  • K160645 — PreSep Oligon Oximetry Catheter (June 16, 2016)
  • K140129 — PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHET (July 2, 2014)
  • K110167 — PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN) (February 18, 2011)
  • K091268 — HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS (September 18, 2009)
  • K062999 — OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN (November 3, 2006)
  • K061585 — OPTICATH CENTRAL VENOUS OXIMETRY CATHETER (October 5, 2006)
  • K061450 — HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE C (August 4, 2006)
  • K061159 — OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN (June 26, 2006)
  • K060093 — PRESEP OLIGON OXIMETRY CATHETERS (April 28, 2006)

FDA data resources