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510(k) K771116

CATHETER, PO2, INTRAVASUCLAR, CITADEL by Sherwood Medical Industries — Product Code CCE

K771116 is an FDA 510(k) premarket notification submitted by Sherwood Medical Industries for the device "CATHETER, PO2, INTRAVASUCLAR, CITADEL". The FDA issued a decision of Substantially Equivalent on September 15, 1977. The device falls under product code CCE (Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling), a Class II device regulated under 21 CFR 868.1200. Sherwood Medical Industries has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1977
Date Received
June 16, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
Device Class
Class II
Regulation Number
868.1200
Review Panel
AN
Submission Type

Other clearances by Sherwood Medical Industries

  • K801070 — SHERWOOD DISPOSABLE ENDOMETRIAL SAMPLES (July 21, 1980)
  • K801071 — LANCER GLUCOSE RATE REAGENT KIT (May 23, 1980)
  • K792014 — LANCER L-INA BUFFER, POLYMER, WASH SOLU (November 13, 1979)
  • K792013 — LANCER L-INA HUMAN REFERENCE SERUM (November 13, 1979)
  • K782077 — LANCER ICE CUBE (April 3, 1979)
  • K790523 — ARGYLE ESOPHAGEAL STETHOSCOPE (March 27, 1979)
  • K790196 — MONOJECT ARTERIAL BLOOD SAMPLING DEVICE (March 13, 1979)
  • K790197 — REAGENT KIT, LANCER GLUCOSE (March 12, 1979)
  • K781459 — MONOJECT SCALE MAGNIFIER (October 24, 1978)
  • K781060 — MONOJECT ENDOSSEOUS DENTAL IMPLANT (August 14, 1978)

Other clearances for product code CCE

  • K935778 — VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM (December 5, 1996)
  • K912145 — SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA (May 5, 1992)
  • K910453 — TOPS NEEDLE TIP PROBE & PVC TIP PROBE (August 13, 1991)
  • K905397 — PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM (May 14, 1991)
  • K896311 — OPTEX BLOOD GAS MONITORING SYSTEM (January 3, 1990)
  • K890624 — TISSUE OXYGEN MONITOR SYSTEM, MODEL II (December 22, 1989)
  • K895150 — CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING (November 28, 1989)
  • K895149 — NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY (November 28, 1989)
  • K884063 — BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR SYSTEM (December 16, 1988)
  • K875225 — UMBILICAL ARTERY OXYGEN SENSOR (March 4, 1988)

FDA data resources