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510(k) K945592

VLV SOLODRAW(TM) DUAL CHAMBER PISTON SYRINGE by Vlv Associates, Inc. — Product Code FMF

K945592 is an FDA 510(k) premarket notification submitted by Vlv Associates, Inc. for the device "VLV SOLODRAW(TM) DUAL CHAMBER PISTON SYRINGE". The FDA issued a decision of Substantially Equivalent on July 14, 1995. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Vlv Associates, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1995
Date Received
November 14, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
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)
  • 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 FMF

  • K260208 — Ultra-Fine™ SAFETY Insulin Syringe (July 13, 2026)
  • K253110 — Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe (June 18, 2026)
  • K260514 — Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low (June 12, 2026)
  • K253112 — Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); (May 21, 2026)
  • K252279 — Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) (April 17, 2026)
  • K253068 — Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe (February 23, 2026)
  • K253769 — Instylla Delivery Kit (December 22, 2025)
  • K252518 — DuoprossTM Smart Cap (Type I) (December 17, 2025)
  • K251089 — EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Sy (December 12, 2025)
  • K250192 — Verisafe Safety Retractable Insulin Syringes (December 10, 2025)

FDA data resources