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FDA 510(k)

INTRAVASCULAR CATHETER

K-Number: K812159 · 1981-08-31

ApplicantPioneer Viggo, Inc.
Decision Date1981-08-31
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INTRAVASCULAR CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Pioneer Viggo, Inc.. It received FDA 510(k) clearance on 1981-08-31 under 510(k) number K812159. 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 INTRAVASCULAR CATHETER?

INTRAVASCULAR CATHETER is a medical device that received FDA 510(k) clearance on 1981-08-31. The listed applicant is Pioneer Viggo, Inc.. The 510(k) number is K812159.

When did INTRAVASCULAR CATHETER receive FDA 510(k) clearance?

INTRAVASCULAR CATHETER received FDA 510(k) clearance on 1981-08-31, under 510(k) number K812159.

Who is the listed applicant for INTRAVASCULAR CATHETER?

The FDA 510(k) record lists Pioneer Viggo, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTRAVASCULAR CATHETER?

The FDA product code for INTRAVASCULAR 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 Pioneer Viggo, Inc. 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.

K823120EXACTA & CONNECTA STOPCOCKS W/EXTENSIONK813454I.V. FILTER-PREVENTK811171VASCULON II I.V. CATHETERK801537START IT WITH & WITHOUT I.V. CATH. UNITK791809BLOOD TRANSFUSION MICROFILTER

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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