FDA 510(k)

GESCO PER-Q-CATH REPAIR KIT

K-Number: K910622 · 1991-03-29

Decision Date1991-03-29

Product CodeLJS

Advisory CommitteeHO

DecisionUnknown

Device Summary

GESCO PER-Q-CATH REPAIR KIT is the device name listed in this FDA 510(k) record. The listed applicant is Gesco Intl., Inc.. It received FDA 510(k) clearance on 1991-03-29 under 510(k) number K910622. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the GESCO PER-Q-CATH REPAIR KIT?

GESCO PER-Q-CATH REPAIR KIT is a medical device that received FDA 510(k) clearance on 1991-03-29. The listed applicant is Gesco Intl., Inc.. The 510(k) number is K910622.

When did GESCO PER-Q-CATH REPAIR KIT receive FDA 510(k) clearance?

GESCO PER-Q-CATH REPAIR KIT received FDA 510(k) clearance on 1991-03-29, under 510(k) number K910622.

Who is the listed applicant for GESCO PER-Q-CATH REPAIR KIT?

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

What is the FDA product code for GESCO PER-Q-CATH REPAIR KIT?

The FDA product code for GESCO PER-Q-CATH REPAIR KIT is LJS.

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Other records listing Gesco Intl., Inc. as applicant

K954422PER-Q-CATH MID-LINE K940953UMBILI-CATH-S K940870UMBILI-CATH K940952UMBILI-CATH-S-DL K941672URI-CATH CATHETER K941232THORA-CATH

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Related Devices (Code: LJS)

K260929Neonav ECG Tip Location SystemNavi Medical Technologies K252373BioFlo 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 Vascular K252792PM2™ 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.