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FDA 510(k)

NIPRO SAFELET CATH

K-Number: K960051 · 1996-03-28

ApplicantNissho Corp.
Decision Date1996-03-28
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NIPRO SAFELET CATH is the device name listed in this FDA 510(k) record. The listed applicant is Nissho Corp.. It received FDA 510(k) clearance on 1996-03-28 under 510(k) number K960051. 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 NIPRO SAFELET CATH?

NIPRO SAFELET CATH is a medical device that received FDA 510(k) clearance on 1996-03-28. The listed applicant is Nissho Corp.. The 510(k) number is K960051.

When did NIPRO SAFELET CATH receive FDA 510(k) clearance?

NIPRO SAFELET CATH received FDA 510(k) clearance on 1996-03-28, under 510(k) number K960051.

Who is the listed applicant for NIPRO SAFELET CATH?

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

What is the FDA product code for NIPRO SAFELET CATH?

The FDA product code for NIPRO SAFELET CATH 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 Nissho Corp. 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.

K954676NIPRO ARTERIAL & VENOUS BLOOD TUBING SET FOR HEMODIALYSISK955182NIPRO ARTERIAL VENOUS FISTULA NEEDLEK955053NIPRO SCALP VEIN SET (DISPOSABL PSV SET)K944355NIPRO BRANDED DISPOSABLE SYRINGES, NEEDLES

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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