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)

TUBETECH IV Administration Set

K-Number: K162951 · 2017-07-28

ApplicantDouglas Medical Products, Inc.
Decision Date2017-07-28
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TUBETECH IV Administration Set is the device name listed in this FDA 510(k) record. The listed applicant is Douglas Medical Products, Inc.. It received FDA 510(k) clearance on 2017-07-28 under 510(k) number K162951. 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 TUBETECH IV Administration Set?

TUBETECH IV Administration Set is a medical device that received FDA 510(k) clearance on 2017-07-28. The listed applicant is Douglas Medical Products, Inc.. The 510(k) number is K162951.

When did TUBETECH IV Administration Set receive FDA 510(k) clearance?

TUBETECH IV Administration Set received FDA 510(k) clearance on 2017-07-28, under 510(k) number K162951.

Who is the listed applicant for TUBETECH IV Administration Set?

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

What is the FDA product code for TUBETECH IV Administration Set?

The FDA product code for TUBETECH IV Administration Set is FPA.

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.

K261530iiSure 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)K251814EZ™ IV Administration SetEpic Medical Pte. , Ltd.

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.

↑