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FDA 510(k)

CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1

K-Number: K991301 · 1999-06-09

ApplicantSims Deltec, Inc.
Decision Date1999-06-09
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1 is the device name listed in this FDA 510(k) record. The listed applicant is Sims Deltec, Inc.. It received FDA 510(k) clearance on 1999-06-09 under 510(k) number K991301. 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 CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1?

CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1 is a medical device that received FDA 510(k) clearance on 1999-06-09. The listed applicant is Sims Deltec, Inc.. The 510(k) number is K991301.

When did CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1 receive FDA 510(k) clearance?

CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1 received FDA 510(k) clearance on 1999-06-09, under 510(k) number K991301.

Who is the listed applicant for CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1?

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

What is the FDA product code for CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1?

The FDA product code for CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1 is FPA.

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Other records listing Sims Deltec, 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.

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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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