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FDA 510(k)

HEMOCLAV VENOUS CATHETER

K-Number: K831801 · 1983-07-07

ApplicantExo, Inc.
Decision Date1983-07-07
Product CodeFIQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HEMOCLAV VENOUS CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Exo, Inc.. It received FDA 510(k) clearance on 1983-07-07 under 510(k) number K831801. The device is classified under product code FIQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOCLAV VENOUS CATHETER?

HEMOCLAV VENOUS CATHETER is a medical device that received FDA 510(k) clearance on 1983-07-07. The listed applicant is Exo, Inc.. The 510(k) number is K831801.

When did HEMOCLAV VENOUS CATHETER receive FDA 510(k) clearance?

HEMOCLAV VENOUS CATHETER received FDA 510(k) clearance on 1983-07-07, under 510(k) number K831801.

Who is the listed applicant for HEMOCLAV VENOUS CATHETER?

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

What is the FDA product code for HEMOCLAV VENOUS CATHETER?

The FDA product code for HEMOCLAV VENOUS CATHETER is FIQ.

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 Exo, 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.

K243239Lung AI (LAI001)K242359Strain AI (SAI001)K232501AI Platform (AIP001)K230497Bladder AI (AIBV01)

Related Devices (Code: FIQ)

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.

K892887ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULAAkcess Medical Products, Inc.K892663S-100 ALLEN-BROWN SHUNTAkcess Medical Products, Inc.K892666SAF-T-SHUNT, S-300 SERIESAkcess Medical Products, Inc.K844692PEDIATRIC SIZED HEMOCATH CATHETERQuinton, Inc.K841791PLUME FISTULA NEEDLEHospal Medical Corp.K840322HEMOFILTRATION CATHETER HF-100Vas-Cath of Canada , Ltd.

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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