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FDA 510(k)

ONECATH L-CATH CATHETER SYSTEM

K-Number: K930473 · 1994-04-07

ApplicantLuther Medical Products, Inc.
Decision Date1994-04-07
Product CodeLJS
Advisory CommitteeHO
DecisionUnknown

Device Summary

ONECATH L-CATH 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 1994-04-07 under 510(k) number K930473. 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 ONECATH L-CATH CATHETER SYSTEM?

ONECATH L-CATH CATHETER SYSTEM is a medical device that received FDA 510(k) clearance on 1994-04-07. The listed applicant is Luther Medical Products, Inc.. The 510(k) number is K930473.

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

ONECATH L-CATH CATHETER SYSTEM received FDA 510(k) clearance on 1994-04-07, under 510(k) number K930473.

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

The FDA product code for ONECATH L-CATH CATHETER SYSTEM is LJS.

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Other records listing Luther Medical Products, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K982797BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICBK980090ONECATH, 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 SELDINGERK940198L-CATH CONNECTOR ASSEMBLYK942103L-CATH CATHETER SYSTEM - PORT L-CATHK925236L CATH(R) CATHETER SYSTEM

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Related Devices (Code: LJS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260929Neonav ECG Tip Location SystemNavi Medical TechnologiesK252373BioFlo 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 VascularK252792PM2™ 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.

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