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510(k) K943206

VARIOUS TUBING by Prn Services, Inc. — Product Code FPK

K943206 is an FDA 510(k) premarket notification submitted by Prn Services, Inc. for the device "VARIOUS TUBING". The FDA issued a decision of Substantially Equivalent on March 9, 1995. The device falls under product code FPK (Tubing, Fluid Delivery), a Class II device regulated under 21 CFR 880.5440. Prn Services, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1995
Date Received
July 5, 1994
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 Prn Services, Inc.

  • K902330 — E-Z FLO + SET (September 21, 1990)
  • K897065 — PORT INFUSION SET (PIS) INFUSION SET (IS) (February 16, 1990)
  • K882598 — 250 ML BAG W/Y INJECT. & 12 EXTENSION SET (November 1, 1988)
  • K884053 — PRN PLUS + INFUSION SET (October 31, 1988)
  • K875155 — 60 ML RESERVOIR BAG, ITEM #200 (February 16, 1988)
  • K860222 — 70 ML RESERVOIR BAG AND ADMINISTRATION SETS (June 9, 1986)

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