Home / 510(k) Clearances / K800504

510(k) K800504

OXYGEN CONNECTING TUBES by Medi-Craft , Ltd. — Product Code BYX

K800504 is an FDA 510(k) premarket notification submitted by Medi-Craft , Ltd. for the device "OXYGEN CONNECTING TUBES". The FDA issued a decision of Substantially Equivalent on March 18, 1980. The device falls under product code BYX (Tubing, Pressure And Accessories), a Class I device regulated under 21 CFR 868.5860. Medi-Craft , Ltd. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1980
Date Received
March 4, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubing, Pressure And Accessories
Device Class
Class I
Regulation Number
868.5860
Review Panel
AN
Submission Type

Other clearances by Medi-Craft , Ltd.

  • K861949 — SUCTION CATHETER KIT (October 22, 1986)
  • K800508 — STOMACH TUBES (April 8, 1980)
  • K800507 — FEEDING TUBES (April 8, 1980)
  • K800505 — URETHRAL CATHETER (April 8, 1980)
  • K800510 — RECTAL & HARRIS FLUSH TUBES (April 8, 1980)
  • K800509 — CONNECTING TUBES (March 25, 1980)
  • K800506 — OXYGEN CATHETER (March 25, 1980)
  • K800503 — SUCTION CATHETER (March 18, 1980)

Other clearances for product code BYX

  • K011134 — OXYGEN SUPPLY TUBING, MODEL 1115 (June 13, 2001)
  • K955656 — NORTH STATE PLASTICS AEROSOL TEE (March 6, 1996)
  • K943110 — GAS SAMPLING INTERFACES (August 19, 1994)
  • K935835 — BUSSE PLASTIC TUBING CONNECTORS AND ACCESSORIES (January 12, 1994)
  • K931033 — MF CHEMETRON STYLE MEDICAL GAS WALL OUTLETS (June 1, 1993)
  • K931043 — MF OHMEDA STYLE MEDICAL GAS WALL OUTLETS (June 1, 1993)
  • K913422 — OXYGEN TUBING, 81503 (January 30, 1992)
  • K914980 — HEX, QUAD, OR RAIL BLOCK MANIFOLD ACCESSORIES (January 21, 1992)
  • K912763 — OHMEDA STYLE CHECK UNITS (FEMALE COUPLERS) (October 15, 1991)
  • K905091 — VARIOUS MALE QUICK CONNECTS. (March 4, 1991)

FDA data resources