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)

I.V. ADMINISTRATION SET CONNECTING DEVICE

K-Number: K940832 · 1996-01-23

ApplicantSierra Medical Devices
Decision Date1996-01-23
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

I.V. ADMINISTRATION SET CONNECTING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Sierra Medical Devices. It received FDA 510(k) clearance on 1996-01-23 under 510(k) number K940832. 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 I.V. ADMINISTRATION SET CONNECTING DEVICE?

I.V. ADMINISTRATION SET CONNECTING DEVICE is a medical device that received FDA 510(k) clearance on 1996-01-23. The listed applicant is Sierra Medical Devices. The 510(k) number is K940832.

When did I.V. ADMINISTRATION SET CONNECTING DEVICE receive FDA 510(k) clearance?

I.V. ADMINISTRATION SET CONNECTING DEVICE received FDA 510(k) clearance on 1996-01-23, under 510(k) number K940832.

Who is the listed applicant for I.V. ADMINISTRATION SET CONNECTING DEVICE?

The FDA 510(k) record lists Sierra Medical Devices as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I.V. ADMINISTRATION SET CONNECTING DEVICE?

The FDA product code for I.V. ADMINISTRATION SET CONNECTING DEVICE is FPA.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sierra Medical Devices 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.

K921429SOLUTION ADMINISTRATION SET

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.

↑