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FDA 510(k)

MDC SAFE STEP SAFETY I.V. CATHETER SYSTEM

K-Number: K960013 · 1996-02-13

ApplicantMDC Research , Ltd.
Decision Date1996-02-13
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MDC SAFE STEP SAFETY I.V. CATHETER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is MDC Research , Ltd.. It received FDA 510(k) clearance on 1996-02-13 under 510(k) number K960013. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MDC SAFE STEP SAFETY I.V. CATHETER SYSTEM?

MDC SAFE STEP SAFETY I.V. CATHETER SYSTEM is a medical device that received FDA 510(k) clearance on 1996-02-13. The listed applicant is MDC Research , Ltd.. The 510(k) number is K960013.

When did MDC SAFE STEP SAFETY I.V. CATHETER SYSTEM receive FDA 510(k) clearance?

MDC SAFE STEP SAFETY I.V. CATHETER SYSTEM received FDA 510(k) clearance on 1996-02-13, under 510(k) number K960013.

Who is the listed applicant for MDC SAFE STEP SAFETY I.V. CATHETER SYSTEM?

The FDA 510(k) record lists MDC Research , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MDC SAFE STEP SAFETY I.V. CATHETER SYSTEM?

The FDA product code for MDC SAFE STEP SAFETY I.V. CATHETER SYSTEM is FOZ.

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 MDC Research , Ltd. 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.

K022959SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1K973012MDC SAFE STEP SAFETY BLOOD COLLECTION NEEDLE SYSTEM

Related Devices (Code: FOZ)

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.

K260432Ruby Intravascular CatheterVenocare, Inc.K260165Unimpregnated Central Venous CatheterSpectrum VascularK261041ClearSafe Closed SystemMedSource Labs, LLCK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLCK253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.

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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