FDA 510(k)

L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER

K-Number: K974543 · 1998-02-10

Decision Date1998-02-10

Product CodeFOZ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER 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 1998-02-10 under 510(k) number K974543. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER?

L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER is a medical device that received FDA 510(k) clearance on 1998-02-10. The listed applicant is Luther Medical Products, Inc.. The 510(k) number is K974543.

When did L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER receive FDA 510(k) clearance?

L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER received FDA 510(k) clearance on 1998-02-10, under 510(k) number K974543.

Who is the listed applicant for L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER?

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 MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER?

The FDA product code for L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER is FOZ.

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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)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

View on FDA Database →

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