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FDA 510(k)

COMBICATH CATHETER

K-Number: K974642 · 1998-03-13

ApplicantPlastimed Laboratoire Pharmaceutique
Decision Date1998-03-13
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

COMBICATH CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Plastimed Laboratoire Pharmaceutique. It received FDA 510(k) clearance on 1998-03-13 under 510(k) number K974642. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMBICATH CATHETER?

COMBICATH CATHETER is a medical device that received FDA 510(k) clearance on 1998-03-13. The listed applicant is Plastimed Laboratoire Pharmaceutique. The 510(k) number is K974642.

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

COMBICATH CATHETER received FDA 510(k) clearance on 1998-03-13, under 510(k) number K974642.

Who is the listed applicant for COMBICATH CATHETER?

The FDA 510(k) record lists Plastimed Laboratoire Pharmaceutique as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMBICATH CATHETER?

The FDA product code for COMBICATH CATHETER is EOQ.

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 Plastimed Laboratoire Pharmaceutique 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.

K992424SELDIFLEX LONG-TERM CENTRAL VENOUS CATHETER(40CM & 60CM IN LENGTH), MODELS 63244J20 & 63246J20

Related Devices (Code: EOQ)

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.

K261637Single-use Flexible BronchoscopeHunan Vathin Medical Instrument Co., Ltd.K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/SK2540263.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U)Flexicare Medical Limited.K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.K254037LungFlow Airway CatheterFree Flow Medical, Inc.K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm Corporation

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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