FDA 510(k)

L-CATH PEEL AWAY SYSTEM CATHETER

K-Number: K920755 · 1993-06-07

Decision Date1993-06-07

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

L-CATH PEEL AWAY SYSTEM CATHETER 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 1993-06-07 under 510(k) number K920755. 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 PEEL AWAY SYSTEM CATHETER?

L-CATH PEEL AWAY SYSTEM CATHETER is a medical device that received FDA 510(k) clearance on 1993-06-07. The listed applicant is Luther Medical Products, Inc.. The 510(k) number is K920755.

When did L-CATH PEEL AWAY SYSTEM CATHETER receive FDA 510(k) clearance?

L-CATH PEEL AWAY SYSTEM CATHETER received FDA 510(k) clearance on 1993-06-07, under 510(k) number K920755.

Who is the listed applicant for L-CATH PEEL AWAY SYSTEM CATHETER?

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 PEEL AWAY SYSTEM CATHETER?

The FDA product code for L-CATH PEEL AWAY SYSTEM CATHETER 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

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