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510(k) K910906

CENTURION KLEEN-NEEDLE SYSTEM I.V. EXTENSION SETS by Tri-State Hospital Supply Corp. — Product Code FPK

K910906 is an FDA 510(k) premarket notification submitted by Tri-State Hospital Supply Corp. for the device "CENTURION KLEEN-NEEDLE SYSTEM I.V. EXTENSION SETS". The FDA issued a decision of Substantially Equivalent on April 1, 1991. The device falls under product code FPK (Tubing, Fluid Delivery), a Class II device regulated under 21 CFR 880.5440. Tri-State Hospital Supply Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1991
Date Received
March 5, 1991
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 Tri-State Hospital Supply Corp.

  • K080448 — CENTURION PROTECTIVE RESTRAINT, SCR SERIES (August 28, 2008)
  • K080524 — CENTURION SORBAVIEW OTC (April 23, 2008)
  • K942353 — CENTURION UMBILICAL CATHETER (August 15, 1995)
  • K945977 — CENTURION(R) SITE GUARD(R) TRANSPARENT DRESSING/TRANSPAENT FILM DRESSING (March 29, 1995)
  • K931748 — CENTLURION DISP STERI DENTAL/HYGIENE PACK/TRAYS (February 25, 1994)
  • K935491 — CENTURION MOGEN CLAMP/CIRCUMCISION (STER/NON STER) (February 17, 1994)
  • K923812 — CENTURION DISPOSABLE INSTRUMENTS (December 17, 1992)
  • K897100 — CENTURION VAGINAL SPECULUM (March 16, 1990)
  • K896320 — CENTURION KLEEN-NEEDLE SYSTEM (January 11, 1990)
  • K893647 — COPOLYESTER FILM DRESSING (October 16, 1989)

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