Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Solution Set with 1.2 Micron Air Eliminating Filter

K-Number: K161808 · 2017-06-21

ApplicantBaxter Healthcare Corporation
Decision Date2017-06-21
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Solution Set with 1.2 Micron Air Eliminating Filter is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2017-06-21 under 510(k) number K161808. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Solution Set with 1.2 Micron Air Eliminating Filter?

Solution Set with 1.2 Micron Air Eliminating Filter is a medical device that received FDA 510(k) clearance on 2017-06-21. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K161808.

When did Solution Set with 1.2 Micron Air Eliminating Filter receive FDA 510(k) clearance?

Solution Set with 1.2 Micron Air Eliminating Filter received FDA 510(k) clearance on 2017-06-21, under 510(k) number K161808.

Who is the listed applicant for Solution Set with 1.2 Micron Air Eliminating Filter?

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

What is the FDA product code for Solution Set with 1.2 Micron Air Eliminating Filter?

The FDA product code for Solution Set with 1.2 Micron Air Eliminating Filter is FPA.

Other records listing Baxter Healthcare Corporation 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.

PMA P210036Agent, absorbable hemostatic, non-collagen basedK251745Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)PMA P990009Absorbable collagen hemostatic agent with thrombinK251640SIGMA Spectrum Infusion Pump with Master Drug LibraryK251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)PMA P100030Sealant, polymerizing

View all 53 devices →

Related Devices (Code: FPA)

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.

K261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)K251814EZ™ IV Administration SetEpic Medical Pte. , Ltd.

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.

↑