Home / 510(k) Clearances / K060339

510(k) K060339

KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY by Tyco Healthcare/Kendall — Product Code NGT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2006
Date Received
February 10, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Saline, Vascular Access Flush
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.

Other clearances by Tyco Healthcare/Kendall

  • K051805 — KENDALL SCD SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE THIGH), KENDALL SCD LEXPRES S (October 13, 2005)
  • K040511 — SCD EXPRESS PORTABLE COMPRESSION SYSTEM (June 28, 2004)
  • K040196 — KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS (May 5, 2004)

Other clearances for product code NGT

  • K250884 — 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe (December 2, 2025)
  • K233623 — Praxiject™ SP 0.9% NaCl (February 27, 2024)
  • K231724 — Flush Syringe (Prefilled 0.9% normal saline solution) (November 9, 2023)
  • K231363 — Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, (September 27, 2023)
  • K223584 — Pre-Filled Normal Saline Flush Syringe (August 12, 2023)
  • K230756 — TK Pre-Filled Normal Saline Flush Syringe (August 12, 2023)
  • K231161 — 0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe (July 21, 2023)
  • K231754 — Praxiject™ 0.9% NaCl (July 13, 2023)
  • K214080 — Pentaflush (July 20, 2022)
  • K220060 — Pre-filled Syringe with Saline (June 10, 2022)