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FDA 510(k)

SAFECONNECT VALVE (CATALOG NO. XXXX)

K-Number: K955775 · 1996-11-15

ApplicantFaulding Medical Device Co.
Decision Date1996-11-15
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SAFECONNECT VALVE (CATALOG NO. XXXX) 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 1996-11-15 under 510(k) number K955775. 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 SAFECONNECT VALVE (CATALOG NO. XXXX)?

SAFECONNECT VALVE (CATALOG NO. XXXX) is a medical device that received FDA 510(k) clearance on 1996-11-15. The listed applicant is Faulding Medical Device Co.. The 510(k) number is K955775.

When did SAFECONNECT VALVE (CATALOG NO. XXXX) receive FDA 510(k) clearance?

SAFECONNECT VALVE (CATALOG NO. XXXX) received FDA 510(k) clearance on 1996-11-15, under 510(k) number K955775.

Who is the listed applicant for SAFECONNECT VALVE (CATALOG NO. XXXX)?

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 SAFECONNECT VALVE (CATALOG NO. XXXX)?

The FDA product code for SAFECONNECT VALVE (CATALOG NO. XXXX) 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/100MLK970909SAFE-CONNECT I.V. SETK970789SAFE-CONNECT VIAL DISPENSING SPIKEK971266SAFE-CONNECT Y-SITE ADAPTER CATALOG NO. 681518K970524SAFE-CONNECT I.V. EXTENSION 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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