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510(k) K200463

Huber Needle Infusion Set, Safety Huber Needle Infusion Set by Jiangsu Caina Medical Co.,Ltd — Product Code PTI

K200463 is an FDA 510(k) premarket notification submitted by Jiangsu Caina Medical Co.,Ltd for the device "Huber Needle Infusion Set, Safety Huber Needle Infusion Set". The FDA issued a decision of Substantially Equivalent on April 7, 2021. The device falls under product code PTI (Non-Coring (Huber) Needle), a Class II device regulated under 21 CFR 880.5570. Jiangsu Caina Medical Co.,Ltd has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2021
Date Received
February 25, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Non-Coring (Huber) Needle
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

The non-coring needle (Huber) is utilized to gain access into a subcutaneous implanted intravascular infusion port but can also be used to access other non-vascular implanted devices with similar septums.

Other clearances by Jiangsu Caina Medical Co.,Ltd

  • K232781 — Safety Sliding Blood Collection Set (March 7, 2024)
  • K233190 — ENFit Adaptor (January 18, 2024)
  • K230635 — Pen Needle (June 2, 2023)
  • K220184 — Pump Alignment Syringe (July 21, 2022)
  • K211593 — Enteral Pump Syringe (September 30, 2021)
  • K210217 — Needleless Connector (May 17, 2021)
  • K201356 — Plastic LOR Syringe (February 12, 2021)
  • K200027 — Blood Collection Needle with/without Holder, Safety Blood Collection Needle with (September 9, 2020)
  • K193022 — Retractable Safety Insulin Syringe (July 20, 2020)
  • K193526 — Syringe with safety needle, Safety needle (July 17, 2020)

Other clearances for product code PTI

  • K252355 — K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing (November 26, 2025)
  • K251138 — Promisemed Safety Huber Needles (May 13, 2025)
  • K243332 — Promisemed Safety Huber Needles (March 14, 2025)
  • K241353 — PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set (November 27, 2024)
  • K230715 — Promisemed Safety Huber Needle (June 8, 2023)
  • K213823 — Intera Refill Kit (March 16, 2022)
  • K211121 — Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolu (October 14, 2021)
  • K170881 — ISP Safety Huber Needle Infusion Set (December 14, 2017)
  • K170897 — Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle wit (November 3, 2017)
  • K171735 — PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set (August 8, 2017)

FDA data resources