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510(k) K103740

SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE by Spectra Medical Devices, Inc. — Product Code NGT

K103740 is an FDA 510(k) premarket notification submitted by Spectra Medical Devices, Inc. for the device "SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE". The FDA issued a decision of Substantially Equivalent on July 29, 2011. The device falls under product code NGT (Saline, Vascular Access Flush), a Class II device regulated under 21 CFR 880.5200. Spectra Medical Devices, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2011
Date Received
December 22, 2010
Clearance Type
Traditional
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 Spectra Medical Devices, Inc.

  • K163292 — Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford (September 8, 2017)
  • K151069 — SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle (February 5, 2016)
  • K142791 — Spectra Soft Tissue Biopsy Needles (January 21, 2015)
  • K082689 — STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE (March 20, 2009)
  • K082580 — SPECTRA GUIDEWIRE INTRODUCER NEEDLE (December 8, 2008)
  • K082674 — SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA (November 28, 2008)
  • K081524 — SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PL (July 29, 2008)

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)
  • K213522 — AMSafe Pre-Filled Normal Saline Flush Syringe (March 22, 2022)

FDA data resources