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510(k) K233277

Device
Filter Needle for Single Use
Applicant
Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
510(k) number
K233277
Product code
FPB
Decision
Substantially Equivalent (SESE)
Decision date
2024-05-10
Date received
2023-09-29
Regulation
880.5440
Classification name
Filter, Infusion Line
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Chunyu Wang
Address
104, 301, 302, Bldg. 12, Bldg. 1,619 Wangmei Rd.Inping St., Linping District Hangzhou CN 311199 311199

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FPB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K143583Cathivex ¿GV filter unitsMerck Millipore , Ltd.2015-08-11
K113227NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTERBaxter Healthcare Corp2011-12-08
K021293ARTERIA BLOOD FILTERArteria Medical Science, Inc.2002-08-22
K993379PALL SUPOR AEF FILTERPall Corp.1999-12-16
K9746610.2 U BACTERIAL FILTERSims Deltec, Inc.1998-02-11
K964283AUTOPRIMEArbor Technologies, Inc.1997-01-22
K954331PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER)Pall Biomedical Products Co.1997-01-09
K933523I.V. FILTER SETMediziv Medical Products 1987 , Ltd.1995-05-19
K94162840 MICRON BLOOD TRANSFUSION FILTERDouglas Medical Products Corp.1995-02-16
K9426251.2 MICRON AIR ELIMINATING FILTERThe Medi-Dose Group1994-10-07
K943127PHARMASSURE LARGE VOLUME TRANSFER FILTERSGelman Sciences, Inc.1994-09-29
K9425322 MICRON AIR ELIMINATING FILTERMedi-Dose, Inc.1994-08-17
K941684IVEX-2 EXTENSION SET WITH Y-INJECTION SITEAbbott Laboratories1994-08-03
K942275VIAL VENT FILTERGelman Sciences, Inc.1994-07-26
K940980CHARGED SUPOR(R) FILTER EXTENSION SETB. Braun of America, Inc.1994-07-14