Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CADD Yellow High Volume Administration Set with NRFit connector

K-Number: K172592 · 2018-05-17

Decision Date2018-05-17
Product CodePWH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CADD Yellow High Volume Administration Set with NRFit connector is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2018-05-17 under 510(k) number K172592. The device is classified under product code PWH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CADD Yellow High Volume Administration Set with NRFit connector?

CADD Yellow High Volume Administration Set with NRFit connector is a medical device that received FDA 510(k) clearance on 2018-05-17. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K172592.

When did CADD Yellow High Volume Administration Set with NRFit connector receive FDA 510(k) clearance?

CADD Yellow High Volume Administration Set with NRFit connector received FDA 510(k) clearance on 2018-05-17, under 510(k) number K172592.

Who is the listed applicant for CADD Yellow High Volume Administration Set with NRFit connector?

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

What is the FDA product code for CADD Yellow High Volume Administration Set with NRFit connector?

The FDA product code for CADD Yellow High Volume Administration Set with NRFit connector is PWH.

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.

Other records listing Smiths Medical Asd, 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.

View all 16 devices →

Related Devices (Code: PWH)

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.

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.