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FDA 510(k)

STERILE DESIGN-CUSTOM STERILE IV KIT

K-Number: K842351 · 1984-10-15

ApplicantSterile Design, Inc.
Decision Date1984-10-15
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERILE DESIGN-CUSTOM STERILE IV KIT is the device name listed in this FDA 510(k) record. The listed applicant is Sterile Design, Inc.. It received FDA 510(k) clearance on 1984-10-15 under 510(k) number K842351. 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 STERILE DESIGN-CUSTOM STERILE IV KIT?

STERILE DESIGN-CUSTOM STERILE IV KIT is a medical device that received FDA 510(k) clearance on 1984-10-15. The listed applicant is Sterile Design, Inc.. The 510(k) number is K842351.

When did STERILE DESIGN-CUSTOM STERILE IV KIT receive FDA 510(k) clearance?

STERILE DESIGN-CUSTOM STERILE IV KIT received FDA 510(k) clearance on 1984-10-15, under 510(k) number K842351.

Who is the listed applicant for STERILE DESIGN-CUSTOM STERILE IV KIT?

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

What is the FDA product code for STERILE DESIGN-CUSTOM STERILE IV KIT?

The FDA product code for STERILE DESIGN-CUSTOM STERILE IV KIT is FPA.

Related Clinical Trials

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Other records listing Sterile Design, 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.

K934688STERILE DESIGNK841960CARDIO METRICS INVASIVE PRESSURE MONITK842356CUSTOM STERILE PROCEDURE KITSK841959CARDIO METRIC CUSTOM PERFUSION TUBINGK841958CARDIO METRICS CARDIOTOMY RESERVOIRK834239SDI C-FLEX STERILE LIGHT HANDLE

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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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