FDA 510(k)

L CATH(R) CATHETER SYSTEM

K-Number: K925236 · 1994-03-22

Decision Date1994-03-22

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

L CATH(R) CATHETER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Luther Medical Products, Inc.. It received FDA 510(k) clearance on 1994-03-22 under 510(k) number K925236. 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 L CATH(R) CATHETER SYSTEM?

L CATH(R) CATHETER SYSTEM is a medical device that received FDA 510(k) clearance on 1994-03-22. The listed applicant is Luther Medical Products, Inc.. The 510(k) number is K925236.

When did L CATH(R) CATHETER SYSTEM receive FDA 510(k) clearance?

L CATH(R) CATHETER SYSTEM received FDA 510(k) clearance on 1994-03-22, under 510(k) number K925236.

Who is the listed applicant for L CATH(R) CATHETER SYSTEM?

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

What is the FDA product code for L CATH(R) CATHETER SYSTEM?

The FDA product code for L CATH(R) CATHETER SYSTEM is LJS.

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Other records listing Luther Medical Products, Inc. as applicant

K982797BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB K980090ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM)K974543L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER K940198L-CATH CONNECTOR ASSEMBLY K942103L-CATH CATHETER SYSTEM - PORT L-CATH K930473ONECATH L-CATH CATHETER SYSTEM

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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.