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510(k) K230756

TK Pre-Filled Normal Saline Flush Syringe by Anhui Tiankang Medical Technology Co., Ltd. — Product Code NGT

K230756 is an FDA 510(k) premarket notification submitted by Anhui Tiankang Medical Technology Co., Ltd. for the device "TK Pre-Filled Normal Saline Flush Syringe". The FDA issued a decision of Substantially Equivalent on August 12, 2023. The device falls under product code NGT (Saline, Vascular Access Flush), a Class II device regulated under 21 CFR 880.5200. Anhui Tiankang Medical Technology Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2023
Date Received
March 20, 2023
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 Anhui Tiankang Medical Technology Co., Ltd.

  • K222773 — Feeding Tube (August 17, 2023)
  • K222772 — Oral/Enteral Syringe with ENFit connector (August 17, 2023)
  • K222385 — Bifurcated Needle (December 6, 2022)
  • K220204 — Disposabel Syringe with permanently attached needle, Safety Syringe with permane (July 14, 2022)
  • K212368 — Surgical Face Mask (October 24, 2021)
  • K210464 — Auto Disable Syringe (August 24, 2021)
  • K191639 — TK Insulin Syringe with/without Saftey Retractable Device (September 11, 2020)
  • K191640 — TK Intravascular Administration Set (August 26, 2020)
  • K191644 — TK Safety Needle (August 6, 2020)
  • K191642 — TK Sterile Piston Syringe without Needle (January 6, 2020)

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)
  • 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)
  • K201286 — 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0 (August 11, 2020)

FDA data resources