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FDA 510(k)

IV FILTERSET 0.22 MICROMETER

K-Number: K813446 · 1982-01-05

ApplicantImed Corp.
Decision Date1982-01-05
Product CodeFPB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IV FILTERSET 0.22 MICROMETER is the device name listed in this FDA 510(k) record. The listed applicant is Imed Corp.. It received FDA 510(k) clearance on 1982-01-05 under 510(k) number K813446. 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 IV FILTERSET 0.22 MICROMETER?

IV FILTERSET 0.22 MICROMETER is a medical device that received FDA 510(k) clearance on 1982-01-05. The listed applicant is Imed Corp.. The 510(k) number is K813446.

When did IV FILTERSET 0.22 MICROMETER receive FDA 510(k) clearance?

IV FILTERSET 0.22 MICROMETER received FDA 510(k) clearance on 1982-01-05, under 510(k) number K813446.

Who is the listed applicant for IV FILTERSET 0.22 MICROMETER?

The FDA 510(k) record lists Imed Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IV FILTERSET 0.22 MICROMETER?

The FDA product code for IV FILTERSET 0.22 MICROMETER is FPB.

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Other records listing Imed Corp. 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.

K960512GEMINI PC-ITXK953896THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETSK950153VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) VALVESK951922ADMINISTRATION SETS WITH BALL FLOATK950419THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETSK944320VENTED/NON-VENTED GEMINI ADMINISTRATION SET

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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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