FDA 510(k)

PEDIATRIC RIGHT ATRIAL CATHETER 1/3MM

K-Number: K833442 · 1984-03-19

Decision Date1984-03-19

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PEDIATRIC RIGHT ATRIAL CATHETER 1/3MM is the device name listed in this FDA 510(k) record. The listed applicant is Quinton, Inc.. It received FDA 510(k) clearance on 1984-03-19 under 510(k) number K833442. 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 PEDIATRIC RIGHT ATRIAL CATHETER 1/3MM?

PEDIATRIC RIGHT ATRIAL CATHETER 1/3MM is a medical device that received FDA 510(k) clearance on 1984-03-19. The listed applicant is Quinton, Inc.. The 510(k) number is K833442.

When did PEDIATRIC RIGHT ATRIAL CATHETER 1/3MM receive FDA 510(k) clearance?

PEDIATRIC RIGHT ATRIAL CATHETER 1/3MM received FDA 510(k) clearance on 1984-03-19, under 510(k) number K833442.

Who is the listed applicant for PEDIATRIC RIGHT ATRIAL CATHETER 1/3MM?

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

What is the FDA product code for PEDIATRIC RIGHT ATRIAL CATHETER 1/3MM?

The FDA product code for PEDIATRIC RIGHT ATRIAL CATHETER 1/3MM is LJS.

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Other records listing Quinton, Inc. as applicant

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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.