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510(k) K760524

CATHETER CONNECTOR, ARGYLE TUBING by Sherwood Medical Industries — Product Code GCD

K760524 is an FDA 510(k) premarket notification submitted by Sherwood Medical Industries for the device "CATHETER CONNECTOR, ARGYLE TUBING". The FDA issued a decision of Substantially Equivalent on November 2, 1976. The device falls under product code GCD (Connector, Catheter), a Class I device regulated under 21 CFR 878.4200. Sherwood Medical Industries has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1976
Date Received
August 26, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Connector, Catheter
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
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)
  • K792013 — LANCER L-INA HUMAN REFERENCE SERUM (November 13, 1979)
  • K792014 — LANCER L-INA BUFFER, POLYMER, WASH SOLU (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 GCD

  • K952470 — ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II. (November 28, 1995)
  • K940198 — L-CATH CONNECTOR ASSEMBLY (December 15, 1994)
  • K863446 — ANGIOMED HIGH PRESSURE CONNECTORS (September 23, 1986)
  • K851196 — INCISION DRAIN (June 4, 1985)
  • K851921 — Y CONNECTOR (May 17, 1985)
  • K760382 — CONNECTORS (November 2, 1976)
  • K760203 — TUBE, STERILE NON-CONDUCTIVE CONNECTING (July 19, 1976)

FDA data resources