FDA 510(k)

ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM)

K-Number: K980090 · 1998-03-24

Decision Date1998-03-24

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM) 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 1998-03-24 under 510(k) number K980090. 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 ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM)?

ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM) is a medical device that received FDA 510(k) clearance on 1998-03-24. The listed applicant is Luther Medical Products, Inc.. The 510(k) number is K980090.

When did ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM) receive FDA 510(k) clearance?

ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM) received FDA 510(k) clearance on 1998-03-24, under 510(k) number K980090.

Who is the listed applicant for ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM)?

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, MODEL OC-(16-22 GA., 5CM-60CM)?

The FDA product code for ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM) 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 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 K925236L CATH(R) CATHETER SYSTEM

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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.