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510(k) K922469

PRO-LOK EXTENSION SET(S) by Vlv Associates, Inc. — Product Code FPA

K922469 is an FDA 510(k) premarket notification submitted by Vlv Associates, Inc. for the device "PRO-LOK EXTENSION SET(S)". The FDA issued a decision of Substantially Equivalent on March 15, 1993. 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
March 15, 1993
Date Received
May 26, 1992
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)
  • K964876 — SA.EF(TM) INFUSION PORT II - CONNECTOR AND EXTENSION SET (February 28, 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)
  • 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