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)

SAFE-CONNECT I.V. SET

K-Number: K970909 · 1997-05-06

ApplicantFaulding Medical Device Co.
Decision Date1997-05-06
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SAFE-CONNECT I.V. SET is the device name listed in this FDA 510(k) record. The listed applicant is Faulding Medical Device Co.. It received FDA 510(k) clearance on 1997-05-06 under 510(k) number K970909. 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 SAFE-CONNECT I.V. SET?

SAFE-CONNECT I.V. SET is a medical device that received FDA 510(k) clearance on 1997-05-06. The listed applicant is Faulding Medical Device Co.. The 510(k) number is K970909.

When did SAFE-CONNECT I.V. SET receive FDA 510(k) clearance?

SAFE-CONNECT I.V. SET received FDA 510(k) clearance on 1997-05-06, under 510(k) number K970909.

Who is the listed applicant for SAFE-CONNECT I.V. SET?

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

What is the FDA product code for SAFE-CONNECT I.V. SET?

The FDA product code for SAFE-CONNECT I.V. SET 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 Faulding Medical Device Co. 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.

K962159STERILE AMBULATORY RESERVOIR 60ML/100MLK970789SAFE-CONNECT VIAL DISPENSING SPIKEK971266SAFE-CONNECT Y-SITE ADAPTER CATALOG NO. 681518K970524SAFE-CONNECT I.V. EXTENSION SETK955775SAFECONNECT VALVE (CATALOG NO. XXXX)

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.

↑