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510(k) K942046

PHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VALVE by Pharmacia Deltec, Inc. — Product Code FPA

K942046 is an FDA 510(k) premarket notification submitted by Pharmacia Deltec, Inc. for the device "PHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VALVE". The FDA issued a decision of Substantially Equivalent on October 4, 1994. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Pharmacia Deltec, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1994
Date Received
April 28, 1994
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 Pharmacia Deltec, Inc.

  • K943310 — MODEL 6100 AMBULATORY INFUSION SYSTEM (February 21, 1995)
  • K942161 — LOCKBOX (August 2, 1994)
  • K942024 — PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEM (July 26, 1994)
  • K941445 — EXTENSION SET WITH ANTI-SIPHON VALVE (June 29, 1994)
  • K931073 — CATH-FINDER (May 5, 1994)
  • K932433 — PHERIPHERALLY INSERTED VENOUS CATHETER-Y SITE (May 2, 1994)
  • K932211 — PROCEDURAL TRAY FOR PERIPHERALLY INSERTED VENOUS (May 2, 1994)
  • K932198 — PHARMACIA DELTEC PERIPHERALLY INSERTED VENOUS CATH (May 2, 1994)
  • K932464 — PERIPHERALLYINSRTED VENOUS CATH. ALTERNATE CATH. (May 2, 1994)
  • K932430 — DUAL LUMEN PERIPHERALLY INSERTED VENOUS CATHETER (May 2, 1994)

Other clearances for product code FPA

  • 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)
  • K250616 — Clave™ Neutral-Displacement Needlefree Connectors (June 5, 2025)

FDA data resources