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FDA 510(k)

HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001

K-Number: K021916 · 2002-08-29

ApplicantHarmac Medical Products, Inc.
Decision Date2002-08-29
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001 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 2002-08-29 under 510(k) number K021916. 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 HUBER NEEDLE SAFETY DEVICE, H2984001?

HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001 is a medical device that received FDA 510(k) clearance on 2002-08-29. The listed applicant is Harmac Medical Products, Inc.. The 510(k) number is K021916.

When did HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001 receive FDA 510(k) clearance?

HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001 received FDA 510(k) clearance on 2002-08-29, under 510(k) number K021916.

Who is the listed applicant for HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001?

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 HUBER NEEDLE SAFETY DEVICE, H2984001?

The FDA product code for HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001 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.

K963335HARMAC BALLOON WEDGE PRESSURE CATHETERK962829HARMAC BALLOON ANGIOGRAPHIC CATHETERK962833HARMAC TEMPORARY PACING CATHETER WITH BALLOONK963336HARMAC THERMODILUTION CATHETERK963073HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLETK963074HARMAC QUADPOLAR MAPPING PACING CATHETER

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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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