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510(k) K964876

SA.EF(TM) INFUSION PORT II - CONNECTOR AND EXTENSION SET by Vlv Associates, Inc. — Product Code FPA

K964876 is an FDA 510(k) premarket notification submitted by Vlv Associates, Inc. for the device "SA.EF(TM) INFUSION PORT II - CONNECTOR AND EXTENSION SET". The FDA issued a decision of Substantially Equivalent on February 28, 1997. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Vlv Associates, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1997
Date Received
December 5, 1996
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 Vlv Associates, Inc.

  • K972957 — SA-EF MULTI-LUMEN EXTENSION SET (September 29, 1997)
  • K955783 — VLV SA.EF INFUSION PORT EXTENSION SETS (February 7, 1996)
  • K953791 — VLV SA EF INFUSION PORT (October 30, 1995)
  • K945592 — VLV SOLODRAW(TM) DUAL CHAMBER PISTON SYRINGE (July 14, 1995)
  • K940406 — DISPOSABLE, AMBULATORY, INFUSION PUMPS (September 2, 1994)
  • K933364 — PROMED BIOPSY NEEDLE (February 15, 1994)
  • K922469 — PRO-LOK EXTENSION SET(S) (March 15, 1993)
  • K904217 — PRO-LOK (TM) EXTENSION SETS (October 3, 1990)
  • K901046 — VERSA-LOCK(TM) UNIVERSAL NEEDLE CONNECTOR (June 8, 1990)
  • K901081 — PRO-LOCK(TM) SHIELDING NEEDLE CONNECTOR ASSEMBLY (June 8, 1990)

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