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FDA 510(k)

SAFE-CONNECT VIAL DISPENSING SPIKE

K-Number: K970789 · 1997-05-01

ApplicantFaulding Medical Device Co.
Decision Date1997-05-01
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SAFE-CONNECT VIAL DISPENSING SPIKE 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 1997-05-01 under 510(k) number K970789. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFE-CONNECT VIAL DISPENSING SPIKE?

SAFE-CONNECT VIAL DISPENSING SPIKE is a medical device that received FDA 510(k) clearance on 1997-05-01. The listed applicant is Faulding Medical Device Co.. The 510(k) number is K970789.

When did SAFE-CONNECT VIAL DISPENSING SPIKE receive FDA 510(k) clearance?

SAFE-CONNECT VIAL DISPENSING SPIKE received FDA 510(k) clearance on 1997-05-01, under 510(k) number K970789.

Who is the listed applicant for SAFE-CONNECT VIAL DISPENSING SPIKE?

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 VIAL DISPENSING SPIKE?

The FDA product code for SAFE-CONNECT VIAL DISPENSING SPIKE is LHI.

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. SETK971266SAFE-CONNECT Y-SITE ADAPTER CATALOG NO. 681518K970524SAFE-CONNECT I.V. EXTENSION SETK955775SAFECONNECT VALVE (CATALOG NO. XXXX)

Related Devices (Code: LHI)

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.

K252987ADRx™ Admixture DeviceEpic Medical Pte. , Ltd.K260301Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd.K250345Medline Bag DecanterMedline Industries, LPK251715FlowArt® Vial Access Device VentedAsset MedikalK251676Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)Microtek Medical, LLCK243404HyHub™ and HyHub™ Duo Vial Access DevicesTakeda Pharmaceuticals

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.

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