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FDA 510(k)

PRO.DUCT CATHETER, MODEL CTH03

K-Number: K000135 · 2000-04-10

ApplicantPro. Duct Health, Inc.
Decision Date2000-04-10
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PRO.DUCT CATHETER, MODEL CTH03 is the device name listed in this FDA 510(k) record. The listed applicant is Pro. Duct Health, Inc.. It received FDA 510(k) clearance on 2000-04-10 under 510(k) number K000135. 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 PRO.DUCT CATHETER, MODEL CTH03?

PRO.DUCT CATHETER, MODEL CTH03 is a medical device that received FDA 510(k) clearance on 2000-04-10. The listed applicant is Pro. Duct Health, Inc.. The 510(k) number is K000135.

When did PRO.DUCT CATHETER, MODEL CTH03 receive FDA 510(k) clearance?

PRO.DUCT CATHETER, MODEL CTH03 received FDA 510(k) clearance on 2000-04-10, under 510(k) number K000135.

Who is the listed applicant for PRO.DUCT CATHETER, MODEL CTH03?

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

What is the FDA product code for PRO.DUCT CATHETER, MODEL CTH03?

The FDA product code for PRO.DUCT CATHETER, MODEL CTH03 is KNW.

Related Clinical Trials

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Other records listing Pro. Duct Health, 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.

K001098PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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