Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NIPRO BIO-FLEX CATHETER

K-Number: K022756 · 2002-10-18

ApplicantNipro Medical Corp.
Decision Date2002-10-18
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NIPRO BIO-FLEX CATHETER 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 2002-10-18 under 510(k) number K022756. 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 BIO-FLEX CATHETER?

NIPRO BIO-FLEX CATHETER is a medical device that received FDA 510(k) clearance on 2002-10-18. The listed applicant is Nipro Medical Corp.. The 510(k) number is K022756.

When did NIPRO BIO-FLEX CATHETER receive FDA 510(k) clearance?

NIPRO BIO-FLEX CATHETER received FDA 510(k) clearance on 2002-10-18, under 510(k) number K022756.

Who is the listed applicant for NIPRO BIO-FLEX CATHETER?

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 BIO-FLEX CATHETER?

The FDA product code for NIPRO BIO-FLEX CATHETER 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 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

View all 27 devices →

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.

↑