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FDA 510(k)

HARMAC EXTENSION INFUSION SET

K-Number: K950895 · 1995-09-01

ApplicantHarmac Medical Products, Inc.
Decision Date1995-09-01
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HARMAC EXTENSION INFUSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Harmac Medical Products, Inc.. It received FDA 510(k) clearance on 1995-09-01 under 510(k) number K950895. 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 HARMAC EXTENSION INFUSION SET?

HARMAC EXTENSION INFUSION SET is a medical device that received FDA 510(k) clearance on 1995-09-01. The listed applicant is Harmac Medical Products, Inc.. The 510(k) number is K950895.

When did HARMAC EXTENSION INFUSION SET receive FDA 510(k) clearance?

HARMAC EXTENSION INFUSION SET received FDA 510(k) clearance on 1995-09-01, under 510(k) number K950895.

Who is the listed applicant for HARMAC EXTENSION INFUSION SET?

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

What is the FDA product code for HARMAC EXTENSION INFUSION SET?

The FDA product code for HARMAC EXTENSION INFUSION SET is FPA.

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Other records listing Harmac Medical Products, 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.

K021916HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001K963335HARMAC BALLOON WEDGE PRESSURE CATHETERK962829HARMAC BALLOON ANGIOGRAPHIC CATHETERK962833HARMAC TEMPORARY PACING CATHETER WITH BALLOONK963336HARMAC THERMODILUTION CATHETERK963073HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET

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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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