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Canyon Medical Femoral Bypass Cannulae and Intro

by Canyon Medical Products

510(k) K897026

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK897026 Date26 Feb 1990ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DWF
Device Class
Class II
Regulation
21 CFR Part 870.4210
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a catheter, cannula and tubing, vascular, cardiopulmonary bypass. It is substantially equivalent to a predicate device and classified under product code DWF with regulation number 870.4210.

It is supplied by Canyon Medical Products in Salt Lake City, Utah, and received FDA 510(k) clearance on February 26, 1990, under K897026. The device is intended for cardiovascular use and is not MRI conditional or sterile unless otherwise specified in labeling.

Other devices from Canyon Medical Products

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Canyon Medical Femoral Bypass Cannulae and Intro used for?

    This device is a catheter, cannula and tubing designed for vascular use in cardiopulmonary bypass procedures, intended for cardiovascular applications as specified in its labeling and regulatory filing.

  • How is the Canyon Medical Femoral Bypass Cannulae and Intro supplied and by whom?

    The device is supplied by Canyon Medical Products from their facility in Salt Lake City, Utah, as indicated in the manufacturer and address details provided in the device data.

  • Is the Canyon Medical Femoral Bypass Cannulae and Intro sterile or MRI conditional?

    The device is not sterile or MRI conditional unless otherwise specified in its labeling, as explicitly stated in the description section of the device data.