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FDA 510(k)

INFUSION ADMINISTRATION SET

K-Number: K940053 · 1994-03-28

ApplicantPuritas Health Care, Inc.
Decision Date1994-03-28
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFUSION ADMINISTRATION SET is the device name listed in this FDA 510(k) record. The listed applicant is Puritas Health Care, Inc.. It received FDA 510(k) clearance on 1994-03-28 under 510(k) number K940053. 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 INFUSION ADMINISTRATION SET?

INFUSION ADMINISTRATION SET is a medical device that received FDA 510(k) clearance on 1994-03-28. The listed applicant is Puritas Health Care, Inc.. The 510(k) number is K940053.

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

INFUSION ADMINISTRATION SET received FDA 510(k) clearance on 1994-03-28, under 510(k) number K940053.

Who is the listed applicant for INFUSION ADMINISTRATION SET?

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

What is the FDA product code for INFUSION ADMINISTRATION SET?

The FDA product code for INFUSION ADMINISTRATION SET is FPA.

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Other records listing Puritas Health Care, 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.

K942339SKIN NEUVEAU SCAR TREATMENTK941197SILK*SKIN SCAR TREATMENTK935600TRACHEAL SUCTION CATHETERK935531OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIPK940074Y-TYPE BLOOD ADMINISTRATION SETK940055MULTISET

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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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