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FDA 510(k)

STERILE I.V. START KIT

K-Number: K902810 · 1990-11-13

ApplicantOrion Life Systems, Inc.
Decision Date1990-11-13
Product CodeFPA
Advisory CommitteeHO
DecisionUnknown

Device Summary

STERILE I.V. START KIT is the device name listed in this FDA 510(k) record. The listed applicant is Orion Life Systems, Inc.. It received FDA 510(k) clearance on 1990-11-13 under 510(k) number K902810. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the STERILE I.V. START KIT?

STERILE I.V. START KIT is a medical device that received FDA 510(k) clearance on 1990-11-13. The listed applicant is Orion Life Systems, Inc.. The 510(k) number is K902810.

When did STERILE I.V. START KIT receive FDA 510(k) clearance?

STERILE I.V. START KIT received FDA 510(k) clearance on 1990-11-13, under 510(k) number K902810.

Who is the listed applicant for STERILE I.V. START KIT?

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

What is the FDA product code for STERILE I.V. START KIT?

The FDA product code for STERILE I.V. START KIT is FPA.

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Other records listing Orion Life Systems, 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.

K943835PRE-FILLED SYRINGE W/STERILE .25% ACETC ACIDK943828STERILE WATER FOR IRRIGATIONK943834STERILE .9% SODIUM CHLORIDE SOLUTIONK943831PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATERK943832STERILE .9% SODIUM CHLORIDE FOR IRRATIONK943830PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION

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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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