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510(k) K950597

CORE-RESISTANT HUBER INFUSION SET WITH Y-SITE by Distronic Sterile Products, Inc. — Product Code FPA

K950597 is an FDA 510(k) premarket notification submitted by Distronic Sterile Products, Inc. for the device "CORE-RESISTANT HUBER INFUSION SET WITH Y-SITE". The FDA issued a decision of Substantially Equivalent on July 26, 1995. The device falls under product code FPA (Set, Administration, Intravascular), 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 26, 1995
Date Received
February 9, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
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)
  • K952663 — 60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON (July 14, 1995)
  • K945184 — INTRAVASCULAR ADMINISTRATION SET (February 8, 1995)

Other clearances for product code FPA

  • K254123 — Ecomed Disposable Administration Sets (September 11, 2026)
  • K261530 — iiSure Infusion Set (June 3, 2026)
  • K252543 — AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, (May 4, 2026)
  • K251375 — PuraCath Firefly Needleless Connector IT (9005) (February 12, 2026)
  • K251257 — nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Fre (December 4, 2025)
  • K250325 — BD Alaris Pump Infusion Set (October 30, 2025)
  • K251814 — EZ™ IV Administration Set (August 29, 2025)
  • K251854 — SteadiSet infusion set (August 6, 2025)
  • K243841 — Sparta Infusion Set for Insulin (August 1, 2025)
  • K243392 — Infusomat® Space Volumetric Infusion Pump Administration Sets (July 24, 2025)

FDA data resources