I.V. Filter Set

FDA 510(k) K933523 · Mediziv Medical Products 1987 , Ltd.

Substantially Equivalent

510(k) numberK933523

Submission

Device name
I.V. Filter Set
Applicant
Mediziv Medical Products 1987 , Ltd.
Tel Aviv, IL
Received
July 20, 1993
Decision date
May 19, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FPB – Filter, Infusion Line
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5440
Specialty
General Hospital

Other 510(k)s with product code FPB

510(k)DeviceApplicantDecision
K261403Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A…FPB · Traditional Global Life Sciences Solutions USA, LLC08/31/2026SE
K233277Filter Needle for Single UseFPB · Traditional Hangzhou Qiantang Longyue Biotechnology Co., Ltd.05/10/2024SE
K143583Cathivex ¿GV filter unitsFPB · Traditional Merck Millipore , Ltd.08/11/2015SE
K113227Non-Dehp Micro-Volume Extension Set with 0.22 Micron FilterFPB · Special Baxter Healthcare Corp12/08/2011SE
K021293Arteria Blood FilterFPB · Traditional Arteria Medical Science, Inc.08/22/2002SE
K993379Pall Supor Aef FilterFPB · Traditional Pall Corp.12/16/1999SE
K9746610.2 U Bacterial FilterFPB · Traditional Sims Deltec, Inc.02/11/1998SE
K964283AutoprimeFPB · Traditional Arbor Technologies, Inc.01/22/1997SE
K954331Pall Lea Filter (Lipid Emulsion Filter) (I.V. Filter)FPB · Traditional Pall Biomedical Products Co.01/09/1997SE
K94162840 Micron Blood Transfusion FilterFPB · Traditional Douglas Medical Products Corp.02/16/1995SE

More from Douglas Medical Products Corp.

510(k)DeviceDecision
K933898Huber Needle SetsFPA · Traditional 09/27/1995SE
K933524Extention SetFPK · Traditional 05/23/1995SE
K933522Introducer Needle (Several Sizes)DYB · Traditional 02/21/1995SE

Questions and answers

When was I.V. Filter Set cleared by the FDA?

I.V. Filter Set (K933523) received a 510(k) decision of Substantially Equivalent on May 19, 1995, 668 days after the submission was received.

What is the product code of K933523?

The FDA product code is FPB – Filter, Infusion Line, a Class II (moderate risk) device regulated under 21 CFR 880.5440.