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FDA 510(k)

HAEMOTROL MODEL #HT-SB/6 BURETTE SET

K-Number: K921594 · 1992-12-24

ApplicantHaemotronic, Inc.
Decision Date1992-12-24
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HAEMOTROL MODEL #HT-SB/6 BURETTE SET is the device name listed in this FDA 510(k) record. The listed applicant is Haemotronic, Inc.. It received FDA 510(k) clearance on 1992-12-24 under 510(k) number K921594. 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 HAEMOTROL MODEL #HT-SB/6 BURETTE SET?

HAEMOTROL MODEL #HT-SB/6 BURETTE SET is a medical device that received FDA 510(k) clearance on 1992-12-24. The listed applicant is Haemotronic, Inc.. The 510(k) number is K921594.

When did HAEMOTROL MODEL #HT-SB/6 BURETTE SET receive FDA 510(k) clearance?

HAEMOTROL MODEL #HT-SB/6 BURETTE SET received FDA 510(k) clearance on 1992-12-24, under 510(k) number K921594.

Who is the listed applicant for HAEMOTROL MODEL #HT-SB/6 BURETTE SET?

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

What is the FDA product code for HAEMOTROL MODEL #HT-SB/6 BURETTE SET?

The FDA product code for HAEMOTROL MODEL #HT-SB/6 BURETTE SET is FPA.

Related Clinical Trials

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.

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Other records listing Haemotronic, 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.

K921597CAVH/CVVH/CAVHD SET MODEL #HT-HF/505K921595Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2K913361DRAIN/PRIMING/RECIRCULATION BAG

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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