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FDA 510(k)

NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER

K-Number: K113227 · 2011-12-08

ApplicantBaxter Healthcare Corp
Decision Date2011-12-08
Product CodeFPB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 2011-12-08 under 510(k) number K113227. 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 NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER?

NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER is a medical device that received FDA 510(k) clearance on 2011-12-08. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K113227.

When did NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER receive FDA 510(k) clearance?

NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER received FDA 510(k) clearance on 2011-12-08, under 510(k) number K113227.

Who is the listed applicant for NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER?

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

What is the FDA product code for NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER?

The FDA product code for NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON 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.K021293ARTERIA BLOOD FILTERArteria Medical Science, Inc.K993379PALL SUPOR AEF FILTERPall Corp.K9746610.2 U BACTERIAL FILTERSims Deltec, Inc.K964283AUTOPRIMEArbor Technologies, 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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