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FDA 510(k)

NIPRO SAFELET CATH

K-Number: K013287 · 2001-12-03

ApplicantNipro Medical Corp.
Decision Date2001-12-03
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 Nipro Medical Corp.. It received FDA 510(k) clearance on 2001-12-03 under 510(k) number K013287. 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 2001-12-03. The listed applicant is Nipro Medical Corp.. The 510(k) number is K013287.

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

NIPRO SAFELET CATH received FDA 510(k) clearance on 2001-12-03, under 510(k) number K013287.

Who is the listed applicant for NIPRO SAFELET CATH?

The FDA 510(k) record lists Nipro Medical 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.

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Other records listing Nipro Medical 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.

K093985NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLEK081210NIPRO SAFETOUCH HUBER INFUSTION SETK072024NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693K063368NIPRO BIOHOLE NEEDLEK063721NIPRO SAFETOUCH II GAMMAK052474NIPRO HYPODERMIC NEEDLE

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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

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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