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FDA 510(k)

HEMO-NATE SYRINGE BLOOD FILTER

K-Number: K781815 · 1979-02-27

ApplicantGisco Intl.
Decision Date1979-02-27
Product CodeFPB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HEMO-NATE SYRINGE BLOOD FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Gisco Intl.. It received FDA 510(k) clearance on 1979-02-27 under 510(k) number K781815. 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 HEMO-NATE SYRINGE BLOOD FILTER?

HEMO-NATE SYRINGE BLOOD FILTER is a medical device that received FDA 510(k) clearance on 1979-02-27. The listed applicant is Gisco Intl.. The 510(k) number is K781815.

When did HEMO-NATE SYRINGE BLOOD FILTER receive FDA 510(k) clearance?

HEMO-NATE SYRINGE BLOOD FILTER received FDA 510(k) clearance on 1979-02-27, under 510(k) number K781815.

Who is the listed applicant for HEMO-NATE SYRINGE BLOOD FILTER?

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

What is the FDA product code for HEMO-NATE SYRINGE BLOOD FILTER?

The FDA product code for HEMO-NATE SYRINGE BLOOD FILTER is FPB.

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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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