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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 Mar 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 11 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 25, 1982
Date Received
Mar 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
510(k)

Other clearances by Oximetrix, Inc.

  • K853018 — MODEL 3000 OPTICATH COMPUTER (Jan 13, 1986)
  • K842622 — HEMO STATIC/ESU SCALPEL SYSTEM (Oct 23, 1984)
  • K833966 — PUMP INFUSION WEARABLE INFUSION PUMP (Jan 25, 1984)
  • K823007 — OPTICATH HEPARIN COATED, FLOW-DIRECT (Nov 1, 1982)
  • K821056 — FLOW DIRECTED THERMAL-DILUTION CATHETER (May 18, 1982)
  • K821057 — FLOW DIRECTED THERMAL-DILUTION INFUSION (May 18, 1982)
  • K811391 — OXIMETRIX ACCU SAT CPB (Jul 20, 1981)
  • K791868 — OXIMETRIX SHAW HEMOSTATIC SURG. SYS. (Jan 4, 1980)
  • K781879 — HEATER, OXIMETER SYSTEM (Jan 8, 1979)
  • K781134 — CATHETER, THERMAL DILUTION FIBEROPTIC (Aug 17, 1978)

Other clearances for product code DQE

  • K172423 — PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry… (Feb 20, 2018)
  • K160645 — PreSep Oligon Oximetry Catheter (Jun 16, 2016)
  • K140129 — PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY… (Jul 2, 2014)
  • K110167 — PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN) (Feb 18, 2011)
  • K091268 — HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS (Sep 18, 2009)
  • K062999 — OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN (Nov 3, 2006)
  • K061585 — OPTICATH CENTRAL VENOUS OXIMETRY CATHETER (Oct 5, 2006)
  • K061450 — HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE… (Aug 4, 2006)
  • K061159 — OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN (Jun 26, 2006)
  • K060093 — PRESEP OLIGON OXIMETRY CATHETERS (Apr 28, 2006)

FDA data resources