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FDA 510(k)

PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER)

K-Number: K954331 · 1997-01-09

ApplicantPall Biomedical Products Co.
Decision Date1997-01-09
Product CodeFPB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) is the device name listed in this FDA 510(k) record. The listed applicant is Pall Biomedical Products Co.. It received FDA 510(k) clearance on 1997-01-09 under 510(k) number K954331. The device is classified under product code FPB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER)?

PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) is a medical device that received FDA 510(k) clearance on 1997-01-09. The listed applicant is Pall Biomedical Products Co.. The 510(k) number is K954331.

When did PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) receive FDA 510(k) clearance?

PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) received FDA 510(k) clearance on 1997-01-09, under 510(k) number K954331.

Who is the listed applicant for PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER)?

The FDA 510(k) record lists Pall Biomedical Products Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER)?

The FDA product code for PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) is FPB.

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Other records listing Pall Biomedical Products Co. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K960993PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST)K905794PALL 3N1 FILTERK902518LD-SIX ARTERIAL BLOOD FILTER FOR EXTRA. SERVICEK884534PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTERK875095PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANEK875094ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE

View all 28 devices →

Related Devices (Code: FPB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261403Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion FilterGlobal Life Sciences Solutions USA, LLCK233277Filter Needle for Single UseHangzhou Qiantang Longyue Biotechnology Co., Ltd.K113227NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTERBaxter Healthcare CorpK021293ARTERIA BLOOD FILTERArteria Medical Science, Inc.K993379PALL SUPOR AEF FILTERPall Corp.K9746610.2 U BACTERIAL FILTERSims Deltec, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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