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Repair Kits for Right Atrial Cath

by Quinton, Inc. 510(k)

Active United States

510(k) K832774

Overview

Repair Kits for Right Atrial Cath are catheter, intravascular, therapeutic, long-term greater than 30 days devices. They are classified as Class II medical devices under regulation number 880.5970.

The device received FDA 510(k) clearance via traditional pathway on January 3, 1984, under K832774, and is manufactured by Quinton, Inc. in Mchenry, Illinois. It is supplied as a kit for repair purposes related to right atrial catheters.

AI-generated from registry data, 23 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK832774 Date3 Jan 1984ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LJS
Device Class
Class II
Regulation
21 CFR Part 880.5970
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Other devices from Quinton, Inc.

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Questions

  • What is the intended use of Repair Kits for Right Atrial Cath?

    Repair Kits for Right Atrial Cath are intended for repair purposes related to right atrial catheters, serving as intravascular, therapeutic, long-term devices designed for use greater than 30 days.

  • How is the Repair Kit for Right Atrial Cath supplied and is it reusable?

    The device is supplied as a kit for repair purposes and is intended for single-use only, as it is a therapeutic catheter system not designed for reprocessing or reuse.

  • What regulatory pathway and clearance date apply to this device?

    The Repair Kits for Right Atrial Cath received FDA 510(k) clearance via the traditional pathway on January 3, 1984, under submission number K832774, and is classified as a Class II device.