Home / 510(k) Clearances / K870416

510(k) K870416

LP EXTENSION SETS by North Coast Medi-Tek — Product Code FPK

K870416 is an FDA 510(k) premarket notification submitted by North Coast Medi-Tek for the device "LP EXTENSION SETS". The FDA issued a decision of Substantially Equivalent on April 6, 1987. The device falls under product code FPK (Tubing, Fluid Delivery), a Class II device regulated under 21 CFR 880.5440. North Coast Medi-Tek has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 1987
Date Received
February 3, 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 North Coast Medi-Tek

  • K870419 — IVR-SP CUSTOM ANGIOGRAPHY TRAY (May 11, 1987)
  • K870420 — PTC-6 AND PTC-8 PERCUTANEOUS CHOLANGIOGRAPHY (April 14, 1987)
  • K870418 — MYA-1 AND MYT-1 MYELOGRAM TRAY (March 17, 1987)
  • K870417 — RCT-1, RCT-2, RCT-3 ARTHROGRAM TRAY (March 5, 1987)
  • K854095 — BIOPSY TRAY I & II (November 25, 1985)

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