Home / 510(k) Clearances / K800506

510(k) K800506

OXYGEN CATHETER by Medi-Craft , Ltd. — Product Code BZB

K800506 is an FDA 510(k) premarket notification submitted by Medi-Craft , Ltd. for the device "OXYGEN CATHETER". The FDA issued a decision of Substantially Equivalent on March 25, 1980. The device falls under product code BZB (Catheter, Nasal, Oxygen), a Class I device regulated under 21 CFR 868.5350. Medi-Craft , Ltd. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1980
Date Received
March 4, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Nasal, Oxygen
Device Class
Class I
Regulation Number
868.5350
Review Panel
AN
Submission Type

Other clearances by Medi-Craft , Ltd.

  • K861949 — SUCTION CATHETER KIT (October 22, 1986)
  • K800507 — FEEDING TUBES (April 8, 1980)
  • K800508 — STOMACH TUBES (April 8, 1980)
  • K800505 — URETHRAL CATHETER (April 8, 1980)
  • K800510 — RECTAL & HARRIS FLUSH TUBES (April 8, 1980)
  • K800509 — CONNECTING TUBES (March 25, 1980)
  • K800503 — SUCTION CATHETER (March 18, 1980)
  • K800504 — OXYGEN CONNECTING TUBES (March 18, 1980)

Other clearances for product code BZB

  • K896731 — OXYGEN CATHETERS (March 30, 1990)
  • K843466 — PHARMA-PLAST OXYGEN CATHETER (November 19, 1984)
  • K833351 — DEMAND OXYGEN CONTROLLER (March 19, 1984)
  • K830984 — OXYGEN CATHETERS (May 18, 1983)
  • K820370 — NASAL OXYGEN CATHETER (April 16, 1982)
  • K791273 — CONPHAR OXYGEN CATHETER-STERILE (July 24, 1979)
  • K790057 — CATHETER, OXYGEN (February 5, 1979)

FDA data resources