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510(k) K230756

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

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.

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  • 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)

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  • 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)
  • K220060 — Pre-filled Syringe with Saline (June 10, 2022)
  • K213522 — AMSafe Pre-Filled Normal Saline Flush Syringe (March 22, 2022)