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FDA 510(k)

I.V. FILTER EXTENSION SET

K-Number: K912848 · 1991-11-29

ApplicantFiltertek, Inc.
Decision Date1991-11-29
Product CodeFPB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

I.V. FILTER EXTENSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Filtertek, Inc.. It received FDA 510(k) clearance on 1991-11-29 under 510(k) number K912848. 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 I.V. FILTER EXTENSION SET?

I.V. FILTER EXTENSION SET is a medical device that received FDA 510(k) clearance on 1991-11-29. The listed applicant is Filtertek, Inc.. The 510(k) number is K912848.

When did I.V. FILTER EXTENSION SET receive FDA 510(k) clearance?

I.V. FILTER EXTENSION SET received FDA 510(k) clearance on 1991-11-29, under 510(k) number K912848.

Who is the listed applicant for I.V. FILTER EXTENSION SET?

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

What is the FDA product code for I.V. FILTER EXTENSION SET?

The FDA product code for I.V. FILTER EXTENSION SET is FPB.

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Other records listing Filtertek, 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.

K981548NFC NEEDLEFREE CONNECTOR MODEL 69900K981547NFC NEEDLEFREE Y-SITE, MODEL 69970K914792PN 62290 0.22 MICRON MICRO INFUS I.V. EXTEN SETK912394TRANSDUCER PROTECTORK911451I.V. EXTENDER SETK904912TRANSDUCER PROTECTOR

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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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