Home / 510(k) Clearances / K233277

510(k) K233277

Filter Needle for Single Use by Hangzhou Qiantang Longyue Biotechnology Co., Ltd. — Product Code FPB

K233277 is an FDA 510(k) premarket notification submitted by Hangzhou Qiantang Longyue Biotechnology Co., Ltd. for the device "Filter Needle for Single Use". The FDA issued a decision of Substantially Equivalent on May 10, 2024. The device falls under product code FPB (Filter, Infusion Line), a Class II device regulated under 21 CFR 880.5440. Hangzhou Qiantang Longyue Biotechnology Co., Ltd. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2024
Date Received
September 29, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Infusion Line
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Hangzhou Qiantang Longyue Biotechnology Co., Ltd.

  • K260301 — Vial Adapter (June 5, 2026)
  • K233287 — Vent Vial Adapter (July 26, 2024)
  • K233284 — Vial Adapter with Filter (May 1, 2024)
  • K222718 — Vial Adapter (March 10, 2023)

Other clearances for product code FPB

  • K143583 — Cathivex ¿GV filter units (August 11, 2015)
  • K113227 — NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER (December 8, 2011)
  • K021293 — ARTERIA BLOOD FILTER (August 22, 2002)
  • K993379 — PALL SUPOR AEF FILTER (December 16, 1999)
  • K974661 — 0.2 U BACTERIAL FILTER (February 11, 1998)
  • K964283 — AUTOPRIME (January 22, 1997)
  • K954331 — PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) (January 9, 1997)
  • K933523 — I.V. FILTER SET (May 19, 1995)
  • K941628 — 40 MICRON BLOOD TRANSFUSION FILTER (February 16, 1995)
  • K942625 — 1.2 MICRON AIR ELIMINATING FILTER (October 7, 1994)

FDA data resources