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510(k) K952663

60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON GILYRT, INJ. SITE, CLAMP by Distronic Sterile Products, Inc. — Product Code FPK

K952663 is an FDA 510(k) premarket notification submitted by Distronic Sterile Products, Inc. for the device "60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON GILYRT, INJ. SITE, CLAMP". The FDA issued a decision of Substantially Equivalent on July 14, 1995. The device falls under product code FPK (Tubing, Fluid Delivery), a Class II device regulated under 21 CFR 880.5440. Distronic Sterile Products, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1995
Date Received
June 12, 1995
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 Distronic Sterile Products, Inc.

  • K955709 — WINGED & SUBCUTANEOUS INFUSION SETS (February 21, 1996)
  • K955732 — VENTED SOLUTION SET (February 21, 1996)
  • K954984 — MINIBORE STOPCOCK SET (January 23, 1996)
  • K954983 — EXTENSION SET WITH CHECK VALVE (January 23, 1996)
  • K952664 — SOLUTION ADMINISTRATION SET (August 7, 1995)
  • K950597 — CORE-RESISTANT HUBER INFUSION SET WITH Y-SITE (July 26, 1995)
  • K945184 — INTRAVASCULAR ADMINISTRATION SET (February 8, 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