FDA 510(k)

RIGHT ATRIAL CATHETER

K-Number: K930630 · 1994-02-07

Decision Date1994-02-07

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent for Some Indications

Device Summary

RIGHT ATRIAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Akcess Medical Products, Inc.. It received FDA 510(k) clearance on 1994-02-07 under 510(k) number K930630. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the RIGHT ATRIAL CATHETER?

RIGHT ATRIAL CATHETER is a medical device that received FDA 510(k) clearance on 1994-02-07. The listed applicant is Akcess Medical Products, Inc.. The 510(k) number is K930630.

When did RIGHT ATRIAL CATHETER receive FDA 510(k) clearance?

RIGHT ATRIAL CATHETER received FDA 510(k) clearance on 1994-02-07, under 510(k) number K930630.

Who is the listed applicant for RIGHT ATRIAL CATHETER?

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

What is the FDA product code for RIGHT ATRIAL CATHETER?

The FDA product code for RIGHT ATRIAL CATHETER is LJS.

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Other records listing Akcess Medical Products, 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

View on FDA Database →

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