Home / 510(k) Clearances / K874360

510(k) K874360

PLASTIC TUBING CONNECTOR by American Medical Technology, Inc. — Product Code FPK

K874360 is an FDA 510(k) premarket notification submitted by American Medical Technology, Inc. for the device "PLASTIC TUBING CONNECTOR". The FDA issued a decision of Substantially Equivalent on November 17, 1987. The device falls under product code FPK (Tubing, Fluid Delivery), a Class II device regulated under 21 CFR 880.5440. American Medical Technology, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 1987
Date Received
October 23, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubing, Fluid Delivery
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by American Medical Technology, Inc.

  • K963808 — CHOICE POWERED WHEELCHAIR (February 12, 1997)
  • K905745 — AMETEC MASY MODULAR ANGIOSCOPE SYSTEM (April 23, 1992)
  • K874567 — RESUSCITATOR (February 29, 1988)
  • K874430 — NEEDLE CONTAINER (January 4, 1988)
  • K873313 — SURGICAL DRAPE (September 4, 1987)

Other clearances for product code FPK

  • K131517 — MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING (August 2, 2013)
  • K063114 — DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES (February 9, 2007)
  • K063239 — LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, (December 11, 2006)
  • K052431 — MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801 (November 29, 2005)
  • K041178 — EMPOWER TRANSFER SET, (CAT. NO. 7725) (July 16, 2004)
  • K031808 — MEDRAD SWABBABLE VALVE TRANSFER SET (July 11, 2003)
  • K022431 — MEDRAD TRANSFER SET (September 5, 2002)
  • K965208 — POLYFIN EXTENSION SET, MODELS 126 AND 128 (February 26, 1997)
  • K953864 — SILCLEAR TUBING (MODIFICATION) (November 6, 1995)
  • K950508 — SYSMEX SF-3000 (November 3, 1995)

FDA data resources