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FDA 510(k)

CATHETER TUNNELER

K-Number: K972555 · 1997-12-22

ApplicantGerard Medical, Inc.
Decision Date1997-12-22
Product CodeLJS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CATHETER TUNNELER is the device name listed in this FDA 510(k) record. The listed applicant is Gerard Medical, Inc.. It received FDA 510(k) clearance on 1997-12-22 under 510(k) number K972555. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATHETER TUNNELER?

CATHETER TUNNELER is a medical device that received FDA 510(k) clearance on 1997-12-22. The listed applicant is Gerard Medical, Inc.. The 510(k) number is K972555.

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

CATHETER TUNNELER received FDA 510(k) clearance on 1997-12-22, under 510(k) number K972555.

Who is the listed applicant for CATHETER TUNNELER?

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

What is the FDA product code for CATHETER TUNNELER?

The FDA product code for CATHETER TUNNELER is LJS.

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 Gerard Medical, 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.

K974533TRIMPORTK945060HERNIA MESH INTRODUCTION SYSTEMK936207ENDO-NEEDLE INSTRUMENT

Related Devices (Code: LJS)

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.

K260929Neonav ECG Tip Location SystemNavi Medical TechnologiesK252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve TechnologySpectrum VascularK252792PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc.K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); HydrAccess Vascular, Inc.K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)Access Vascular, Inc.K243484PM2+ System and SmartPICC StyletPiccolo Medical, 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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