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FDA 510(k)

FUJI CATHETER, MODEL CTH001

K-Number: K983867 · 1999-06-09

ApplicantWindy Hill Technology, Inc.
Decision Date1999-06-09
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FUJI CATHETER, MODEL CTH001 is the device name listed in this FDA 510(k) record. The listed applicant is Windy Hill Technology, Inc.. It received FDA 510(k) clearance on 1999-06-09 under 510(k) number K983867. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJI CATHETER, MODEL CTH001?

FUJI CATHETER, MODEL CTH001 is a medical device that received FDA 510(k) clearance on 1999-06-09. The listed applicant is Windy Hill Technology, Inc.. The 510(k) number is K983867.

When did FUJI CATHETER, MODEL CTH001 receive FDA 510(k) clearance?

FUJI CATHETER, MODEL CTH001 received FDA 510(k) clearance on 1999-06-09, under 510(k) number K983867.

Who is the listed applicant for FUJI CATHETER, MODEL CTH001?

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

What is the FDA product code for FUJI CATHETER, MODEL CTH001?

The FDA product code for FUJI CATHETER, MODEL CTH001 is KNW.

Related Clinical Trials

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Other records listing Windy Hill Technology, 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.

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Related Devices (Code: KNW)

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.

K260517Automatic Core Biopsy InstrumentZhejiang Curaway Medical Technology Co., Ltd.K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc.K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc.K260572Marrow MarxmanMedimetrix, LLCK261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd.K260365Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery CharDevicor Medical Products, Inc.

Official Source

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