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FDA 510(k)

IV SETS 2000 SERIES (HS-200,2L0,220)

K-Number: K761327 · 1977-01-31

ApplicantExtracorporeal Medical Specialities, Inc.
Decision Date1977-01-31
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IV SETS 2000 SERIES (HS-200,2L0,220) is the device name listed in this FDA 510(k) record. The listed applicant is Extracorporeal Medical Specialities, Inc.. It received FDA 510(k) clearance on 1977-01-31 under 510(k) number K761327. 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 IV SETS 2000 SERIES (HS-200,2L0,220)?

IV SETS 2000 SERIES (HS-200,2L0,220) is a medical device that received FDA 510(k) clearance on 1977-01-31. The listed applicant is Extracorporeal Medical Specialities, Inc.. The 510(k) number is K761327.

When did IV SETS 2000 SERIES (HS-200,2L0,220) receive FDA 510(k) clearance?

IV SETS 2000 SERIES (HS-200,2L0,220) received FDA 510(k) clearance on 1977-01-31, under 510(k) number K761327.

Who is the listed applicant for IV SETS 2000 SERIES (HS-200,2L0,220)?

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

What is the FDA product code for IV SETS 2000 SERIES (HS-200,2L0,220)?

The FDA product code for IV SETS 2000 SERIES (HS-200,2L0,220) is FPA.

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Other records listing Extracorporeal Medical Specialities, 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.

K843955EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATORK840262HANCOCK PERICARDIAL PATCHK840532HEMOPERFUSION SYSTEM TP-400K840057EXP* 500 PARALLEL PLATE DIALYZERK840146EXP* 700 PARALLEL PLATE DIALYZERK832547ULTRAFILTRATION CONTROLLER

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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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure 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)

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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