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FDA 510(k)

FAST FLOW XX (AQUEOUS SOLUTION FILTER)

K-Number: K860372 · 1986-05-30

ApplicantHealthtek, Inc.
Decision Date1986-05-30
Product CodeFPB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FAST FLOW XX (AQUEOUS SOLUTION FILTER) is the device name listed in this FDA 510(k) record. The listed applicant is Healthtek, Inc.. It received FDA 510(k) clearance on 1986-05-30 under 510(k) number K860372. 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 FAST FLOW XX (AQUEOUS SOLUTION FILTER)?

FAST FLOW XX (AQUEOUS SOLUTION FILTER) is a medical device that received FDA 510(k) clearance on 1986-05-30. The listed applicant is Healthtek, Inc.. The 510(k) number is K860372.

When did FAST FLOW XX (AQUEOUS SOLUTION FILTER) receive FDA 510(k) clearance?

FAST FLOW XX (AQUEOUS SOLUTION FILTER) received FDA 510(k) clearance on 1986-05-30, under 510(k) number K860372.

Who is the listed applicant for FAST FLOW XX (AQUEOUS SOLUTION FILTER)?

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

What is the FDA product code for FAST FLOW XX (AQUEOUS SOLUTION FILTER)?

The FDA product code for FAST FLOW XX (AQUEOUS SOLUTION FILTER) is FPB.

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Other records listing Healthtek, Inc. 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.

K923448EMPTY SOLUTION TRANSFER CONTAINER W/ DETACH LEGK913985TRANSFER-AID(TM)K913608SNAPPERK881590ADFUSE(TM)K874495ADCOMP 4000 HP SYSTEMK873848RETROBULBAR NEEDLE

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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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