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510(k) K933524

EXTENTION SET by Mediziv Medical Products 1987 , Ltd. — Product Code FPK

K933524 is an FDA 510(k) premarket notification submitted by Mediziv Medical Products 1987 , Ltd. for the device "EXTENTION SET". The FDA issued a decision of Substantially Equivalent on May 23, 1995. The device falls under product code FPK (Tubing, Fluid Delivery), a Class II device regulated under 21 CFR 880.5440. Mediziv Medical Products 1987 , Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1995
Date Received
July 20, 1993
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 Mediziv Medical Products 1987 , Ltd.

  • K933898 — HUBER NEEDLE SETS (September 27, 1995)
  • K933523 — I.V. FILTER SET (May 19, 1995)
  • K933522 — INTRODUCER NEEDLE (SEVERAL SIZES) (February 21, 1995)

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